FDA 510(k) Application Details - K101657

Device Classification Name Forceps, Biopsy, Electric

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510(K) Number K101657
Device Name Forceps, Biopsy, Electric
Applicant BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH, MA 01752 US
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Contact ASHLEY PYLE
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Regulation Number 876.4300

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Classification Product Code KGE
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Date Received 06/11/2010
Decision Date 10/05/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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