The following data is part of a premarket notification filed by Medical Dynamics, Inc. with the FDA for Surgical Video Camera And Accessories.
Device ID | K934682 |
510k Number | K934682 |
Device Name: | SURGICAL VIDEO CAMERA AND ACCESSORIES |
Classification | Camera, Television, Endoscopic, Without Audio |
Applicant | MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
Contact | Jo Brehm |
Correspondent | Jo Brehm MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
Product Code | FWF |
CFR Regulation Number | 878.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-30 |
Decision Date | 1994-02-15 |