FDA 510(k) Application Details - K011496

Device Classification Name Cystourethroscope

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510(K) Number K011496
Device Name Cystourethroscope
Applicant RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 CORPORATE WOODS PKWY.
VERNON HILLS, IL 60061 US
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Contact ROBERT L CASARSA
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Regulation Number 876.1500

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Classification Product Code FBO
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Date Received 05/15/2001
Decision Date 08/10/2001
Decision SESE - SUBST EQUIV
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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