The following data is part of a premarket notification filed by Reznik Instruments with the FDA for Fiber Optic Light Source.
| Device ID | K812202 |
| 510k Number | K812202 |
| Device Name: | FIBER OPTIC LIGHT SOURCE |
| Classification | Hysteroscope (and Accessories) |
| Applicant | REZNIK INSTRUMENTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-04 |
| Decision Date | 1981-09-29 |