The following data is part of a premarket notification filed by Biometric Products, Inc. with the FDA for Model Mc-1 Surgical Video Camera.
| Device ID | K863376 |
| 510k Number | K863376 |
| Device Name: | MODEL MC-1 SURGICAL VIDEO CAMERA |
| Classification | Camera, Television, Endoscopic, Without Audio |
| Applicant | BIOMETRIC PRODUCTS, INC. 4275 A S.W. 73RD AVE. Miami, FL 33155 |
| Contact | Katchis, Jr |
| Correspondent | Katchis, Jr BIOMETRIC PRODUCTS, INC. 4275 A S.W. 73RD AVE. Miami, FL 33155 |
| Product Code | FWF |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-03 |
| Decision Date | 1986-10-02 |