K900195 is an FDA 510(k) clearance for the MODIFIED GORE-TEX SURGICAL TAPE. This device is classified as a Tape, Surgical, Internal (Class II - Special Controls, product code MCA).
Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on March 13, 1990, 61 days after receiving the submission on January 11, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K900195 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 1990 |
| Decision Date | March 13, 1990 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | MCA — Tape, Surgical, Internal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |