FDA 510(k) Application Details - K030837

Device Classification Name Insufflator, Laparoscopic

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510(K) Number K030837
Device Name Insufflator, Laparoscopic
Applicant W.O.M. WORLD OF MEDICINE AG
368 NORTH ASAPH STREET
ALEXANDRIA, VA 22314 US
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Contact SUSANNE RAAB
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Regulation Number 884.1730

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Classification Product Code HIF
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Date Received 03/17/2003
Decision Date 02/05/2004
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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