AGNES

Electrosurgical, Cutting & Coagulation & Accessories

GOWOONSESANG COSMETICS CO., LTD

The following data is part of a premarket notification filed by Gowoonsesang Cosmetics Co., Ltd with the FDA for Agnes.

Pre-market Notification Details

• Device ID: K160469
• 510k Number: K160469
• Device Name: AGNES
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: GOWOONSESANG COSMETICS CO., LTD (Seohyeon-dong, 4, 5F Cocoplaza), 20, Seohyeon-ro 210beon-gil, Bundang-gu Seongnam-si, KR 463-824
• Contact: Kyeong Tai Ko
• Correspondent: Dongha Lee; KMC, Inc. Room No. 409, ACE Technotower 1-Cha, 38-9, Digital-ro 31-gil, Guro-gu Seoul, KR 152-766
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-02-19
• Decision Date: 2017-01-05
• Summary: summary