The following data is part of a premarket notification filed by Medical Concepts, Inc. with the FDA for Ccm-1 Video Camera System.
| Device ID | K883943 |
| 510k Number | K883943 |
| Device Name: | CCM-1 VIDEO CAMERA 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551064252 | K883943 | 000 |