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(영문) 광주지방법원 2015.09.10 2015구합11356
업무정지처분취소
Text

1. On April 30, 2015, the Defendant’s business suspension against the Plaintiff on April 30, 2012.

Reasons

Basic Facts

On July 6, 2009, the Plaintiff is a company that manufactures plastic tissue taking materials, which are medical appliances, after obtaining permission from the Commissioner of the Korea Food and Drug Administration to manufacture medical appliances.

No. 1 of the No. 12-727, Jun. 11, 2012, as of June 11, 2012, 201, the Plaintiff was granted a license to manufacture a medical device with the following organized fuel materials for use from the Minister of Food and Drug Safety from 2012 to 2013, using the purpose of use from the Minister of Food and Drug Safety as “no safety and validity of the extension of entry alcohol” from 2012 to 30, Sept. 27, 2013, 2013, No. 43-1648, No. 13-1648, Sept. 27, 2013.

(hereinafter referred to as “each medical device” is specified as “Permission Number.” After using minor permission modification materials for a medical device for the purpose of removing hump oil for the purpose of removing hump oil for the purpose of removing hump oil for the purpose of removing humping, and the safety of the entire material for hump oil was at issue, the Director General of the Food and Drug Safety Evaluation Institute changed the part of the matters of the permission for the medical device for the use of the above humpary medical device produced by manufacturers and importers of the above humping components, including the Plaintiff, on October 23, 2014, as follows, and then sent an official door to the instructions of the Plaintiff to re-making the operating manual. The Plaintiff completed the modification of the permission and the instructions of the use in accordance with the direction of the Plaintiff.

Additional Statement of Cautions in Use

1. In cases of absorbing products, serious side effects, such as real names, may occur when injecting them into the bloodline, so that they shall encourage the skin to refrain from using the glusor around snow, such as thin and low risk of injecting them into the bloodline, and especially caution shall be given at the time of procedures;

2. In the case of a product containing non-decomposability raw materials, real names, etc. when such product is injected into the bloodline.

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