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510(k) K780872

Device
CYTOLOGY BRUSH
Applicant
COOPERVISION, INC.
510(k) number
K780872
Product code
BTG  
Decision
Substantially Equivalent (SESE)
Decision date
1978-09-07
Date received
1978-05-30
Regulation
874.4680
Classification name
Brush, Biopsy, Bronchoscope (non-rigid)
Medical specialty
Ear Nose & Throat
Review panel
Pathology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
Permalens House 1 Botley Rd., Hedge End Southampton GB S033HB S033HB

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BTG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251279Disposable Cytology Brush BC-202D/203D SeriesOlympus Medical Systems Corporation2025-06-12
K182927Pulmonary Cytology BrushHobbs Medical, Inc.2020-02-07
K190293Single Use Cytology Brush BC-205DOlympus Medical Systems Corp.2019-08-02
K130357SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSHCovidien, LLC2013-11-06
K820771MICROBIOLOGY SPECIMEN BRUSHMill-Rose Laboratory1982-05-03

Legacy Summary#

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FDA Review#

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