FDA 510(k) Application Details - K003417

Device Classification Name Laparoscope, Gynecologic (And Accessories)

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510(K) Number K003417
Device Name Laparoscope, Gynecologic (And Accessories)
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 884.1720

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Classification Product Code HET
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Date Received 11/02/2000
Decision Date 04/04/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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