The following data is part of a premarket notification filed by Stephen Chakoff, Inc. with the FDA for Chakoff Endoscopy (fiber Optic Light Source Routine).
| Device ID | K950748 |
| 510k Number | K950748 |
| Device Name: | CHAKOFF ENDOSCOPY (FIBER OPTIC LIGHT SOURCE ROUTINE) |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| Subsequent Product Code | FCW |
| Subsequent Product Code | FST |
| Subsequent Product Code | GCT |
| Subsequent Product Code | GEI |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-17 |
| Decision Date | 1995-03-06 |