K910369 is an FDA 510(k) clearance for the INCISION AND DRAINAGE KIT. This device is classified as a Kit, Surgical Instrument, Disposable (Class I - General Controls, product code KDD).
Submitted by Megadyne Medical Products, Inc. (Hauppauge, US). The FDA issued a Cleared decision on March 28, 1991, 58 days after receiving the submission on January 29, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K910369 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1991 |
| Decision Date | March 28, 1991 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KDD — Kit, Surgical Instrument, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |