The following data is part of a premarket notification filed by Epitek, Inc. with the FDA for Anchorage Scope, Model 000003.
| Device ID | K080780 |
| 510k Number | K080780 |
| Device Name: | ANCHORAGE SCOPE, MODEL 000003 |
| Classification | Cystourethroscope |
| Applicant | EPITEK, INC. 4801 W. 81ST STREET SUITE 105 Bloomington, MN 55437 |
| Contact | Werner Hampl |
| Correspondent | Werner Hampl EPITEK, INC. 4801 W. 81ST STREET SUITE 105 Bloomington, MN 55437 |
| Product Code | FBO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-19 |
| Decision Date | 2008-07-30 |
| Summary: | summary |