The following data is part of a premarket notification filed by Leisegang Medical, Inc. with the FDA for Lm-1z Zoom Scope.
| Device ID | K902313 |
| 510k Number | K902313 |
| Device Name: | LM-1Z ZOOM SCOPE |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | LEISEGANG MEDICAL, INC. 6401 CONGRESS AVE. Boca Raton, FL 33487 -2883 |
| Contact | Douglas Kwart |
| Correspondent | Douglas Kwart LEISEGANG MEDICAL, INC. 6401 CONGRESS AVE. Boca Raton, FL 33487 -2883 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-23 |
| Decision Date | 1990-09-04 |