K984448 is an FDA 510(k) clearance for the BIRCOLL BALLOON DISSECTOR, a Expander, Surgical, Skin Graft (Class I — General Controls, product code FZW), submitted by Wells Johnson Co. (Tucson, US). The FDA issued a Cleared decision on January 28, 1999, 45 days after receiving the submission on December 14, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K984448 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 14, 1998 |
| Decision Date | January 28, 1999 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FZW — Expander, Surgical, Skin Graft |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |