K923283 is an FDA 510(k) clearance for the SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Savoy Medical Supply Co., Inc. (Hauppauge, US). The FDA issued a Cleared decision on January 4, 1993, 182 days after receiving the submission on July 6, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K923283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | July 06, 1992 |
| Decision Date | January 04, 1993 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |