K922228 is an FDA 510(k) clearance for the 2ND SKIN STERILE ADHESIVE STRIP. This device is classified as a Tape And Bandage, Adhesive (Class I - General Controls, product code KGX).
Submitted by Spenco Medical Corp. (Waco, US). The FDA issued a Cleared decision on December 11, 1992, 213 days after receiving the submission on May 12, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5240.
| 510(k) Number | K922228 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | May 12, 1992 |
| Decision Date | December 11, 1992 |
| Days to Decision | 213 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KGX — Tape And Bandage, Adhesive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5240 |