The following data is part of a premarket notification filed by Micro-medical Devices, Inc. with the FDA for Arthroscopes And Accessories.
Device ID | K936213 |
510k Number | K936213 |
Device Name: | ARTHROSCOPES AND ACCESSORIES |
Classification | Arthroscope |
Applicant | MICRO-MEDICAL DEVICES, INC. 317 PARAGON WAY Castle Rock, CO 80104 |
Contact | Edwin L Adair, M.d. |
Correspondent | Edwin L Adair, M.d. MICRO-MEDICAL DEVICES, INC. 317 PARAGON WAY Castle Rock, CO 80104 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-29 |
Decision Date | 1994-05-18 |