The following data is part of a premarket notification filed by Fiegert, Inc. with the FDA for Fiegert Endotech Cystoscope.
| Device ID | K970892 |
| 510k Number | K970892 |
| Device Name: | FIEGERT ENDOTECH CYSTOSCOPE |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | FIEGERT, INC. TWO OAKWOOD BLVD. SUITE 160 Hollywood, FL 33020 |
| Contact | Ernesto Hernandez |
| Correspondent | Ernesto Hernandez FIEGERT, INC. TWO OAKWOOD BLVD. SUITE 160 Hollywood, FL 33020 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-11 |
| Decision Date | 1997-05-05 |