The following data is part of a premarket notification filed by Medical Concepts, Inc. with the FDA for Mec-1 Video Combo System.
| Device ID | K883944 |
| 510k Number | K883944 |
| Device Name: | MEC-1 VIDEO COMBO SYSTEM |
| Classification | Camera, Cine, Endoscopic, With Audio |
| Applicant | MEDICAL CONCEPTS, INC. 310 OLIVE ST. Santa Barbara, CA 93101 |
| Contact | Angeli Mancuso |
| Correspondent | Angeli Mancuso MEDICAL CONCEPTS, INC. 310 OLIVE ST. Santa Barbara, CA 93101 |
| Product Code | FTS |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-19 |
| Decision Date | 1988-09-28 |