The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium Prolite Ultra S Mesh.
Device ID | K070192 |
510k Number | K070192 |
Device Name: | ATRIUM PROLITE ULTRA S 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-01-22 |
Decision Date | 2007-03-08 |