The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Resolve Surgical O.r. Towels.
Device ID | K001667 |
510k Number | K001667 |
Device Name: | RESOLVE SURGICAL O.R. TOWELS |
Classification | Drape, Surgical |
Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
Contact | Sharon Robbins |
Correspondent | Sharon Robbins ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-05-31 |
Decision Date | 2000-06-23 |