K895654 is an FDA 510(k) clearance for the SORBEX(TM) SOFT SPONGE. This device is classified as a Dressing, Wound, Occlusive (Class I - General Controls, product code NAD).
Submitted by Fountain Pharmaceuticals, Inc. (Knoxville, US). The FDA issued a Cleared decision on February 20, 1990, 153 days after receiving the submission on September 20, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4020.
| 510(k) Number | K895654 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | September 20, 1989 |
| Decision Date | February 20, 1990 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | NAD — Dressing, Wound, Occlusive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4020 |