The following data is part of a premarket notification filed by Cooper Surgical, Inc. with the FDA for Cooper Surgical Leisegang Colposcope System.
| Device ID | K140754 |
| 510k Number | K140754 |
| Device Name: | COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | COOPER SURGICAL, INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Contact | Tim Lohnes |
| Correspondent | Tim Lohnes COOPER SURGICAL, INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-26 |
| Decision Date | 2014-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937013061 | K140754 | 000 |
| 00888937013054 | K140754 | 000 |
| 00888937013030 | K140754 | 000 |
| 00888937013023 | K140754 | 000 |
| 00888937013016 | K140754 | 000 |
| 00888937013009 | K140754 | 000 |