K971095 is an FDA 510(k) clearance for the OPPORTUNITY SUTURE REMOVAL KIT. This device is classified as a Gauze/sponge, Internal.
Submitted by Opportunity, Inc. (Highland Park, US). The FDA issued a Cleared decision on September 16, 1997, 176 days after receiving the submission on March 24, 1997.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K971095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | March 24, 1997 |
| Decision Date | September 16, 1997 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | EFQ — Gauze/sponge, Internal |
| Device Class | — |