FDA 510(k) Application Details - K934926

Device Classification Name Insufflator, Laparoscopic

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510(K) Number K934926
Device Name Insufflator, Laparoscopic
Applicant ANDRONIC DEVICES, LTD.
SUITE 140
13120 VANIER PLACE
RICHMOND, B.C. CANADA V6V 2J2 V6V 2J2 CA
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Contact ROBERT MACNEIL
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Regulation Number 884.1730

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Classification Product Code HIF
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Date Received 10/14/1993
Decision Date 05/26/1994
Decision SE - Substantially Equivalent
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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