GalaFORM 3D

Surgical Film

TEPHA, INC.

The following data is part of a premarket notification filed by Tepha, Inc. with the FDA for Galaform 3d.

Pre-market Notification Details

• Device ID: K162922
• 510k Number: K162922
• Device Name: GalaFORM 3D
• Classification: Surgical Film
• Applicant: TEPHA, INC. 99 HAYDEN AVENUE Lexington, MA 02421
• Contact: Connie H Garrison
• Correspondent: Connie H Garrison; TEPHA, INC. 99 HAYDEN AVENUE Lexington, MA 02421
• Product Code: OOD
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-10-18
• Decision Date: 2017-02-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00855920006706	K162922	000
00810054980131	K162922	000
00810054980148	K162922	000
00810054980155	K162922	000
00810054980162	K162922	000
00810054980179	K162922	000
00810054980186	K162922	000
00810054980193	K162922	000
00810054980209	K162922	000
00810054980216	K162922	000
00810054980223	K162922	000
00810054980230	K162922	000
00810054980124	K162922	000
00810054980117	K162922	000
00810054980001	K162922	000
00810054980018	K162922	000
00810054980025	K162922	000
00810054980032	K162922	000
00810054980049	K162922	000
00810054980056	K162922	000
00810054980063	K162922	000
00810054980070	K162922	000
00810054980087	K162922	000
00810054980094	K162922	000
00810054980100	K162922	000
00810054980247	K162922	000
00810054980254	K162922	000
00855920006232	K162922	000
00855920006249	K162922	000
00855920006256	K162922	000
00855920006263	K162922	000
00855920006270	K162922	000
00855920006287	K162922	000
00855920006300	K162922	000
00855920006317	K162922	000
00855920006324	K162922	000
00855920006331	K162922	000
00855920006348	K162922	000
00855920006225	K162922	000
00855920006829	K162922	000
00855920006713	K162922	000
00855920006720	K162922	000
00855920006737	K162922	000
00855920006744	K162922	000
00855920006751	K162922	000
00855920006768	K162922	000
00855920006775	K162922	000
00855920006782	K162922	000
00855920006799	K162922	000
00855920006805	K162922	000
00855920006812	K162922	000
00855920006355	K162922	000