K801028 is an FDA 510(k) clearance for the RICA OR SMIC SURGICAL INSTRUMENTS. This device is classified as a Clamp (Class I - General Controls, product code HXD).
Submitted by Robert I. Chien & Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on May 20, 1980, 19 days after receiving the submission on May 1, 1980.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K801028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 1980 |
| Decision Date | May 20, 1980 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | HXD — Clamp |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |