The following data is part of a premarket notification filed by Stephen Chakoff, Inc. with the FDA for Chakoff Endoscopy, Rigid Endoscope.
| Device ID | K951082 |
| 510k Number | K951082 |
| Device Name: | CHAKOFF ENDOSCOPY, RIGID ENDOSCOPE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | STEPHEN CHAKOFF, INC. 15405 SOUTHWEST 72 CT. Miami, FL 33157 |
| Contact | Frank Goldfarbn |
| Correspondent | Frank Goldfarbn STEPHEN CHAKOFF, INC. 15405 SOUTHWEST 72 CT. Miami, FL 33157 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-09 |
| Decision Date | 1995-03-22 |