The following data is part of a premarket notification filed by Diamics, Inc. with the FDA for Diamics Cercol Cervical Sample Collector System.
| Device ID | K062433 |
| 510k Number | K062433 |
| Device Name: | DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM |
| Classification | Spatula, Cervical, Cytological |
| Applicant | DIAMICS, INC. SIX HAMILTON LANDING SUITE 200 Novato, CA 94949 |
| Contact | Peter Gombrich |
| Correspondent | Peter Gombrich DIAMICS, INC. SIX HAMILTON LANDING SUITE 200 Novato, CA 94949 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-21 |
| Decision Date | 2007-03-16 |
| Summary: | summary |