CERVEX-BRUSH

Spatula, Cervical, Cytological

ROVERS B.V.

The following data is part of a premarket notification filed by Rovers B.v. with the FDA for Cervex-brush.

Pre-market Notification Details

• Device ID: K930955
• 510k Number: K930955
• Device Name: CERVEX-BRUSH
• Classification: Spatula, Cervical, Cytological
• Applicant: ROVERS B.V. 108 UNION ST. Rockaway, NJ 07866
• Contact: John Richardson
• Correspondent: John Richardson; ROVERS B.V. 108 UNION ST. Rockaway, NJ 07866
• Product Code: HHT
• CFR Regulation Number: 884.4530 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-02-23
• Decision Date: 1994-05-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613647000595	K930955	000
28719189246395	K930955	000
87191892466018	K930955	000
08719189246056	K930955	000
08719189246247	K930955	000
08719189246506	K930955	000
10382904905245	K930955	000
87191892460016	K930955	000
87191892460252	K930955	000
87191892460566	K930955	000
87191892462546	K930955	000
00187207000290	K930955	000
08719189246261	K930955	000