The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Cosgrove Clamp.
Device ID | K974769 |
510k Number | K974769 |
Device Name: | COSGROVE CLAMP |
Classification | Clamp, Vascular |
Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
Contact | Patricia Sharpe-gregg |
Correspondent | Patricia Sharpe-gregg ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
Product Code | DXC |
CFR Regulation Number | 870.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-12-22 |
Decision Date | 1998-06-12 |
Summary: | summary |