K903448 is an FDA 510(k) clearance for the SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER. This device is classified as a Tissue Expander And Accessories.
Submitted by Medical Engineering Corp. (Paso Robles, US). The FDA issued a Cleared decision on January 14, 1991, 167 days after receiving the submission on July 31, 1990.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K903448 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 1990 |
| Decision Date | January 14, 1991 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | LCJ — Tissue Expander And Accessories |
| Device Class | — |