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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name forceps, biopsy, bronchoscope (non-rigid)
510(k) Number K121186
Device Name RADIAL JAW 4 PULMONARY BIOPSY FORCEPS
Original Applicant
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough,  MA  01752
Original Contact corrie gooding
Regulation Number874.4680
Classification Product Code
BWH  
Date Received04/18/2012
Decision Date 05/16/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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