K970453 is an FDA 510(k) clearance for the B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING. This device is classified as a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic.
Submitted by B.Braun Medical, Inc. (Milwaukee, US). The FDA issued a Cleared decision on April 11, 1997, 79 days after receiving the submission on January 22, 1997.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K970453 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | January 22, 1997 |
| Decision Date | April 11, 1997 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | MGQ — Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Device Class | — |