FDA 510(k) Application Details - K123325

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K123325
Device Name Laparoscope, General & Plastic Surgery
Applicant MEDAFOR, INC.
2700 FREEWAY BLVD
SUITE 800
MINNEAPOLIS, MN 55430 US
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Contact MELISSA YOUNG
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 10/26/2012
Decision Date 01/24/2013
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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