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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
Model M00515181, M00515182, M00515191, M00515192, M00515201, M00515202
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 (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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