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FDA 510(k) Application Details - K031616
Device Classification Name
Insufflator, Hysteroscopic
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510(K) Number
K031616
Device Name
Insufflator, Hysteroscopic
Applicant
W.O.M. WORLD OF MEDICINE AG
320 NORTH COLUMBUS ST.
ALEXANDRIA, VA 22314 US
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Contact
SUSANNE RAAB
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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
05/23/2003
Decision Date
08/13/2003
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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