K884397 is an FDA 510(k) clearance for the PHARMASEAL STERILE WOUND CARE DRESSING. This device is classified as a Dressing, Wound, Drug.
Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on December 27, 1988, 69 days after receiving the submission on October 19, 1988.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K884397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | October 19, 1988 |
| Decision Date | December 27, 1988 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |