FDA 510(k) Application Details - K022318

Device Classification Name Insufflator, Laparoscopic

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510(K) Number K022318
Device Name Insufflator, Laparoscopic
Applicant VOMED VOLZER MEDIZINTECHNIK GMBH & CO.
AMSTEL 320-I
AMSTERDAM 1017AP NL
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Contact DAGMAR MASER
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Regulation Number 884.1730

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Classification Product Code HIF
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Date Received 07/08/2002
Decision Date 09/19/2002
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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