FDA 510(k) Application Details - K991906

Device Classification Name Insufflator, Laparoscopic

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510(K) Number K991906
Device Name Insufflator, Laparoscopic
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 884.1730

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Classification Product Code HIF
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Date Received 05/21/1999
Decision Date 11/23/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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