K983882 is an FDA 510(k) clearance for the MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400. This device is classified as a Spatula, Orthopedic (Class I - General Controls, product code HXR).
Submitted by Micro-Medical Devices, Inc. (Cleveland, US). The FDA issued a Cleared decision on March 15, 1999, 133 days after receiving the submission on November 2, 1998.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K983882 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1998 |
| Decision Date | March 15, 1999 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | HXR — Spatula, Orthopedic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |