The following data is part of a premarket notification filed by Regtec with the FDA for Fritch Ophthalmic Endoscope.
| Device ID | K855151 |
| 510k Number | K855151 |
| Device Name: | FRITCH OPHTHALMIC ENDOSCOPE |
| Classification | Endoscope, Fiber Optic |
| Applicant | REGTEC P.O. BOX 76298 St. Petersburg, FL 33734 |
| Contact | Joann R Schulz |
| Correspondent | Joann R Schulz REGTEC P.O. BOX 76298 St. Petersburg, FL 33734 |
| Product Code | GDB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-26 |
| Decision Date | 1986-02-19 |