The following data is part of a premarket notification filed by Ecleris Usa with the FDA for Ecleris Microstar Colposcope.
| Device ID | K100595 |
| 510k Number | K100595 |
| Device Name: | ECLERIS MICROSTAR COLPOSCOPE |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | Ecleris USA 12225 WORLD TRADE DRIVE SUITE K San Diego, CA 92128 |
| Contact | Raymond J Kelly Iv |
| Correspondent | Raymond J Kelly Iv Ecleris USA 12225 WORLD TRADE DRIVE SUITE K San Diego, CA 92128 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-02 |
| Decision Date | 2010-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B366U1C100W3R000 | K100595 | 000 |
| B366U1C100T1R000 | K100595 | 000 |
| B366U1C100FHD1RX10 | K100595 | 000 |
| B366U1C100F2R010 | K100595 | 000 |
| B366U1C100F1R010 | K100595 | 000 |
| B366U1C100A5R000 | K100595 | 000 |
| B366U1C100A5EIR000 | K100595 | 000 |