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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscope and/or accessories
510(k) Number K120821
Model ML-40
Device Name LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM
Original Applicant
MISDER, LLC
433 park point drive
suite 140
golden,  CO  80401
Original Contact nancy sauer
Regulation Number876.1500
Classification Product Code
KOG  
Subsequent Product Code
GCJ  
Date Received03/19/2012
Decision Date 05/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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