FDA 510(k) Application Details - K090631

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K090631
Device Name Laparoscope, General & Plastic Surgery
Applicant PAJUNK GMBH MEDIZINTECHNOLOGIE
KARL-HALL-STRASSE 01
GEISINGEN, BADEN-WURTTEMBERG 78187 DE
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Contact CHRISTIAN G QUASS
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 03/09/2009
Decision Date 04/16/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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