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510(k) Data Aggregation
K Number
K980356Device Name
CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010
Manufacturer
Date Cleared
1998-04-16
(77 days)
Product Code
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
CANADIAN MEDICAL BRUSH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Cervical Cytology C-Brush is intended for the collection of cervical cells for Pap smear analysis and /or for sexually transmitted disease (STD) testing. The Cervical Cytology C-Brush is not intended for use in pregnant women.
Indication for use are the endocervical collection of specimens used in Pap smear, chlamydia and HPV testing.
Device Description
The Cervical Cytology C-Brush has a truncated cone-shaped brush head composed of nylon bristles joined to a wire shaft. The brush head on the wire shaft is bonded to a plastic handle. To collect cervical cells, the brush end of the Cervical Cytology C-Brush is inserted 1.0 to 1.5 cm into the cervical os until the longest outer bristles of the brush touch the ectocervix. The brush is rotated two full turns in counter - clockwise direction and withdrawn. The brush is then used to spread the specimen onto a glass slide for a Pap smear.
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