FDA 510(k) Application Details - K990662

Device Classification Name Insufflator, Laparoscopic

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510(K) Number K990662
Device Name Insufflator, Laparoscopic
Applicant WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
RUDOLF-DIESEL-RING 20
SAUERLACH D-82054 DE
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Contact S. GRUNWALD
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Regulation Number 884.1730

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Classification Product Code HIF
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Date Received 03/01/1999
Decision Date 09/24/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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