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FDA 510(k) Application Details - K964136
Device Classification Name
Insufflator, Hysteroscopic
More FDA Info for this Device
510(K) Number
K964136
Device Name
Insufflator, Hysteroscopic
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
884.1700
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Classification Product Code
HIG
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More FDA Info for this Product Code
Date Received
10/15/1996
Decision Date
01/10/1997
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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