FDA 510(k) Application Details - K123847

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K123847
Device Name Laparoscope, General & Plastic Surgery
Applicant MICROMEDICS, INC.
1270 Eagan Industrial Rd Ste 120
Saint Paul, MN 55121 US
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Contact JODI L RAUS
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 12/14/2012
Decision Date 01/08/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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