The following data is part of a premarket notification filed by Micro-medical Devices, Inc. with the FDA for Micro Endoscope-stainless Steel, Model Mmd-1300, Micro Endoscope-polyimide,model Mmd-1400.
| Device ID | K983882 |
| 510k Number | K983882 |
| Device Name: | MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400 |
| Classification | Spatula, Orthopedic |
| Applicant | MICRO-MEDICAL DEVICES, INC. 11000 CEDAR AVE. SUITE 445 Cleveland, OH 44106 |
| Contact | Jim Ohneck |
| Correspondent | Jim Ohneck MICRO-MEDICAL DEVICES, INC. 11000 CEDAR AVE. SUITE 445 Cleveland, OH 44106 |
| Product Code | HXR |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-02 |
| Decision Date | 1999-03-15 |
| Summary: | summary |