The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Uni-graft K Dv Patch.
Device ID | K992776 |
510k Number | K992776 |
Device Name: | UNI-GRAFT K DV PATCH |
Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
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 | DXZ |
CFR Regulation Number | 870.3470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-18 |
Decision Date | 1999-11-16 |