PEAK

Material, Impression

Neosil Co., Ltd

The following data is part of a premarket notification filed by Neosil Co., Ltd with the FDA for Peak.

Pre-market Notification Details

• Device ID: K152180
• 510k Number: K152180
• Device Name: PEAK
• Classification: Material, Impression
• Applicant: Neosil Co., Ltd 63, Gongdanseoro 18 Beon-gil, Geumjeong-gu Busan, KR 609-809
• Contact: Park Dong Min
• Correspondent: Priscilla Chung; LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92831
• Product Code: ELW
• CFR Regulation Number: 872.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-08-04
• Decision Date: 2015-10-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08800026400134	K152180	000
08800026400127	K152180	000
08800026400103	K152180	000
18800026400070	K152180	000
08800026400042	K152180	000
08800026400035	K152180	000
18800026400025	K152180	000
18800026400018	K152180	000
08800026400004	K152180	000