FDA 510(k) Application Details - K102336

Device Classification Name Forceps, Biopsy, Bronchoscope (Non-Rigid)

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510(K) Number K102336
Device Name Forceps, Biopsy, Bronchoscope (Non-Rigid)
Applicant Boston Scientific Corporation
2546 FIRST STREET, PROPARK
ALAJUELA CR
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Contact ASHLEY PYLE
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Regulation Number 874.4680

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Classification Product Code BWH
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Date Received 08/18/2010
Decision Date 01/24/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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