The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Askina Hydrocolloid/thin.
Device ID | K973227 |
510k Number | K973227 |
Device Name: | ASKINA HYDROCOLLOID/THIN |
Classification | Bandage, Liquid |
Applicant | B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
Contact | Mark S Alsberge |
Correspondent | Mark S Alsberge B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-27 |
Decision Date | 1999-01-28 |
Summary: | summary |