K973227 is an FDA 510(k) clearance for the ASKINA HYDROCOLLOID/THIN. This device is classified as a Bandage, Liquid (Class I - General Controls, product code KMF).
Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on January 28, 1999, 519 days after receiving the submission on August 27, 1997.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5090.
| 510(k) Number | K973227 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 1997 |
| Decision Date | January 28, 1999 |
| Days to Decision | 519 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KMF — Bandage, Liquid |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5090 |