FDA 510(k) Application Details - K012771

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K012771
Device Name Laparoscope, General & Plastic Surgery
Applicant PAJUNK GMBH
AM HOLZPLATZ 5-7
GEISINGEN D-78187 DE
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Contact MARTIN HANGER
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 08/17/2001
Decision Date 11/14/2001
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 Y
Expedited Review



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