The following data is part of a premarket notification filed by Micro-medical Devices, Inc. with the FDA for The Flat Panel Steirle Drape System(tm), Video Monitor Sterile Drape.
| Device ID | K963675 |
| 510k Number | K963675 |
| Device Name: | THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE |
| Classification | Drape, Surgical |
| 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 | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-13 |
| Decision Date | 1997-01-27 |