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 |