The following data is part of a premarket notification filed by Imagyn Medical, Inc. with the FDA for Imagyn Uroscope.
| Device ID | K953201 |
| 510k Number | K953201 |
| Device Name: | IMAGYN UROSCOPE |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | IMAGYN MEDICAL, INC. 27651 LA PAZ RD. Laguna Niguel, CA 92656 -3917 |
| Contact | Debra A Rinderer |
| Correspondent | Debra A Rinderer IMAGYN MEDICAL, INC. 27651 LA PAZ RD. Laguna Niguel, CA 92656 -3917 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-06 |
| Decision Date | 1995-08-02 |