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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brush, Biopsy, Bronchoscope (Non-Rigid)
510(k) Number K780872
FOIA Releasable 510(k) K780872
Device Name CYTOLOGY BRUSH
Applicant
CooperVision, Inc.
Permalens House
1 Botley Rd., Hedge End
Southampton,  GB S033HB
Correspondent
CooperVision, Inc.
Permalens House
1 Botley Rd., Hedge End
Southampton,  GB S033HB
Regulation Number874.4680
Classification Product Code
BTG  
Date Received05/30/1978
Decision Date 09/07/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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