CERVEX-BRUSH

Spatula, Cervical, Cytological

UNIMAR, INC.

The following data is part of a premarket notification filed by Unimar, Inc. with the FDA for Cervex-brush.

Pre-market Notification Details

• Device ID: K890848
• 510k Number: K890848
• Device Name: CERVEX-BRUSH
• Classification: Spatula, Cervical, Cytological
• Applicant: UNIMAR, INC. 475 DANBURY RD. Wilton, CT 06897
• Contact: Anthony Hemming
• Correspondent: Anthony Hemming; UNIMAR, INC. 475 DANBURY RD. Wilton, CT 06897
• Product Code: HHT
• CFR Regulation Number: 884.4530 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-02-21
• Decision Date: 1989-05-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20888937014390	K890848	000