The following data is part of a premarket notification filed by Cytocore, Inc. with the FDA for Softpap Cervical Cell Collector.
| Device ID | K072381 |
| 510k Number | K072381 |
| Device Name: | SOFTPAP CERVICAL CELL COLLECTOR |
| Classification | Spatula, Cervical, Cytological |
| Applicant | CYTOCORE, INC. 414 NORTH ORLEAN SUITE 502 Chicago, IL 60610 |
| Contact | Richard Domanik |
| Correspondent | Richard Domanik CYTOCORE, INC. 414 NORTH ORLEAN SUITE 502 Chicago, IL 60610 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-24 |
| Decision Date | 2008-01-30 |
| Summary: | summary |