The following data is part of a premarket notification filed by Stephen Chakoff, Inc. with the FDA for Endoscopic Video Camera.
| Device ID | K932628 |
| 510k Number | K932628 |
| Device Name: | ENDOSCOPIC VIDEO CAMERA |
| Classification | Camera, Television, Endoscopic, Without Audio |
| Applicant | STEPHEN CHAKOFF, INC. 15405 SOUTHWEST 72 CT. Miami, FL 33157 |
| Contact | Frank Goldfarb |
| Correspondent | Frank Goldfarb STEPHEN CHAKOFF, INC. 15405 SOUTHWEST 72 CT. Miami, FL 33157 |
| Product Code | FWF |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-01 |
| Decision Date | 1993-10-15 |