K983173 is an FDA 510(k) clearance for the BIATAIN FOAM ADHESIVE DRESSING. This device is classified as a Dressing, Wound, Drug.
Submitted by Coloplast Corp. (Marietta, US). The FDA issued a Cleared decision on December 16, 1998, 97 days after receiving the submission on September 10, 1998.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K983173 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | September 10, 1998 |
| Decision Date | December 16, 1998 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |