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FDA 510(k) Application Details - K121186
Device Classification Name
Forceps, Biopsy, Bronchoscope (Non-Rigid)
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510(K) Number
K121186
Device Name
Forceps, Biopsy, Bronchoscope (Non-Rigid)
Applicant
BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH, MA 01752 US
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CORRIE GOODING
Other 510(k) Applications for this Contact
Regulation Number
874.4680
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Classification Product Code
BWH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/18/2012
Decision Date
05/16/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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