K946245 is an FDA 510(k) clearance for the TIELLE* HYDROPOLYMER DRESSING. This device is classified as a Bandage, Liquid (Class I - General Controls, product code KMF).
Submitted by Johnson & Johnson International (Arlington, US). The FDA issued a Cleared decision on April 11, 1995, 110 days after receiving the submission on December 22, 1994.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5090.
| 510(k) Number | K946245 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1994 |
| Decision Date | April 11, 1995 |
| Days to Decision | 110 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 |