The following data is part of a premarket notification filed by Micro Medical Devices, Inc. with the FDA for Sterile Video Camera Cover And Drape.
| Device ID | K936086 |
| 510k Number | K936086 |
| Device Name: | STERILE VIDEO CAMERA COVER AND DRAPE |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | MICRO MEDICAL DEVICES, INC. 317 PARAGON WAY Castle Rock, CO 80104 |
| Contact | Edwin L Adair |
| Correspondent | Edwin L Adair MICRO MEDICAL DEVICES, INC. 317 PARAGON WAY Castle Rock, CO 80104 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-21 |
| Decision Date | 1994-03-17 |