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 |