The following data is part of a premarket notification filed by Stephen Chakoff, Inc. with the FDA for Sinuscope.
| Device ID | K940317 |
| 510k Number | K940317 |
| Device Name: | SINUSCOPE |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| 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 | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-24 |
| Decision Date | 1995-05-24 |