K922127 is an FDA 510(k) clearance for the HOSPITAL KIT GP 103. This device is classified as a Instrument, Manual, Surgical, General Use (Class I - General Controls, product code MDM).
Submitted by Savoy Medical Supply Co., Inc. (Hauppauge, US). The FDA issued a Cleared decision on March 29, 1993, 327 days after receiving the submission on May 6, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K922127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | May 06, 1992 |
| Decision Date | March 29, 1993 |
| Days to Decision | 327 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | MDM — Instrument, Manual, Surgical, General Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |