The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium C-qur Ovt Mesh.
Device ID | K100076 |
510k Number | K100076 |
Device Name: | ATRIUM C-QUR OVT MESH |
Classification | Mesh, Surgical, Polymeric |
Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
Contact | Jacqueline Emery |
Correspondent | Jacqueline Emery ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-01-12 |
Decision Date | 2010-01-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00650862316445 | K100076 | 000 |
00650862316117 | K100076 | 000 |
00650862316124 | K100076 | 000 |
00650862316261 | K100076 | 000 |
00650862316285 | K100076 | 000 |
00650862316339 | K100076 | 000 |
00650862316360 | K100076 | 000 |
00650862316377 | K100076 | 000 |
00650862316384 | K100076 | 000 |
00650862316100 | K100076 | 000 |