Submission Details
| 510(k) Number | K943229 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 06, 1994 |
| Decision Date | August 19, 1994 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
K943229 is an FDA 510(k) clearance for the DISPOSABLE SURGICAL SCISSORS AND FORCEPS, a Instrument, Surgical, Disposable (Class I — General Controls, product code KDC), submitted by Y.M.K. International Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on August 19, 1994, 44 days after receiving the submission on July 6, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K943229 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 06, 1994 |
| Decision Date | August 19, 1994 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KDC — Instrument, Surgical, Disposable |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |