The following data is part of a premarket notification filed by Stephen Chakoff, Inc. with the FDA for Hysterscope.
| Device ID | K940316 |
| 510k Number | K940316 |
| Device Name: | HYSTERSCOPE |
| Classification | Hysteroscope (and Accessories) |
| 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 | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-24 |
| Decision Date | 1995-11-16 |