FDA 510(k) Application Details - K944959

Device Classification Name Endoscope And/Or Accessories

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510(K) Number K944959
Device Name Endoscope And/Or Accessories
Applicant BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
WATERTOWN, MA US
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Contact MARY P LEGRAW
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Regulation Number 876.1500

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Classification Product Code KOG
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Date Received 10/07/1994
Decision Date 11/04/1994
Decision SE - Substantially Equivalent
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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