The following data is part of a premarket notification filed by Leisegang Medical, Inc. with the FDA for Colposcopes And Accessories.
| Device ID | K940094 |
| 510k Number | K940094 |
| Device Name: | COLPOSCOPES AND ACCESSORIES |
| 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 | 1994-01-07 |
| Decision Date | 1995-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937019933 | K940094 | 000 |
| 00888937012996 | K940094 | 000 |
| 00888937013009 | K940094 | 000 |
| 00888937013016 | K940094 | 000 |
| 00888937013023 | K940094 | 000 |
| 00888937013030 | K940094 | 000 |
| 00888937013047 | K940094 | 000 |
| 00888937013054 | K940094 | 000 |
| 00888937013061 | K940094 | 000 |
| 00888937013078 | K940094 | 000 |
| 00888937013085 | K940094 | 000 |
| 00888937013115 | K940094 | 000 |
| 00888937013122 | K940094 | 000 |
| 00888937013139 | K940094 | 000 |
| 00888937013146 | K940094 | 000 |
| 00888937000085 | K940094 | 000 |