The following data is part of a premarket notification filed by Laboratoire Ccd C/o Washington Regulatory Services with the FDA for Cytobrush.
| Device ID | K890706 |
| 510k Number | K890706 |
| Device Name: | CYTOBRUSH |
| Classification | Spatula, Cervical, Cytological |
| Applicant | LABORATOIRE CCD C/O WASHINGTON REGULATORY SERVICES 23 WELISEWITZ RD. Ringoes, NJ 08551 |
| Contact | Randolph L Cooke |
| Correspondent | Randolph L Cooke LABORATOIRE CCD C/O WASHINGTON REGULATORY SERVICES 23 WELISEWITZ RD. Ringoes, NJ 08551 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-10 |
| Decision Date | 1989-04-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CYTOBRUSH 73652034 1473009 Live/Registered |
MEDSCAND AB 1987-03-30 |