The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium Medical Corporation C-qur Mesh.
Device ID | K050311 |
510k Number | K050311 |
Device Name: | ATRIUM MEDICAL CORPORATION C-QUR MESH |
Classification | Mesh, Surgical, Polymeric |
Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
Contact | Joseph P De Paolo |
Correspondent | Joseph P De Paolo ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-02-08 |
Decision Date | 2006-03-31 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00650862315912 | K050311 | 000 |
00650862315066 | K050311 | 000 |
00650862315073 | K050311 | 000 |
00650862315264 | K050311 | 000 |
00650862315271 | K050311 | 000 |
00650862315288 | K050311 | 000 |
00650862315318 | K050311 | 000 |
00650862315332 | K050311 | 000 |
00650862315349 | K050311 | 000 |
00650862315356 | K050311 | 000 |
00650862315363 | K050311 | 000 |
00650862315370 | K050311 | 000 |
00650862315387 | K050311 | 000 |
00650862315400 | K050311 | 000 |
00650862315424 | K050311 | 000 |
00650862315431 | K050311 | 000 |
00650862315448 | K050311 | 000 |
00650862315059 | K050311 | 000 |