The following data is part of a premarket notification filed by Gynex Corp. with the FDA for Co-1000 Colposcope, Multiple.
| Device ID | K061306 |
| 510k Number | K061306 |
| Device Name: | CO-1000 COLPOSCOPE, MULTIPLE |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | GYNEX CORP. 2789 152ND AVE., NE Redmond, WA 98052 |
| Contact | Karen Cardiff |
| Correspondent | Karen Cardiff GYNEX CORP. 2789 152ND AVE., NE Redmond, WA 98052 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-10 |
| Decision Date | 2006-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| GYNX200LDAT0 | K061306 | 000 |
| GYNX200LDAR0 | K061306 | 000 |
| GYNX200DAT0 | K061306 | 000 |
| GYNX200DAR0 | K061306 | 000 |