FDA 510(k) Application Details - K910716

Device Classification Name Insufflator, Automatic Carbon-Dioxide For Endoscope

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510(K) Number K910716
Device Name Insufflator, Automatic Carbon-Dioxide For Endoscope
Applicant RICHARD WOLF MEDICAL INSTRUMENTS CORP.
7046 LYNDON AVE.
ROSEMONT, IL US
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Contact ROBERT L CASARSA
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Regulation Number 876.1500

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Classification Product Code FCX
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Date Received 02/20/1991
Decision Date 04/16/1991
Decision SE - Substantially Equivalent
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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