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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti Fog Solution And Accessories, Endoscopy
510(k) Number K120821
Device Name LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM
Applicant
MISDER, LLC
433 PARK POINT DRIVE
SUITE 140
GOLDEN,  CO  80401
Applicant Contact NANCY SAUER
Correspondent
MISDER, LLC
433 PARK POINT DRIVE
SUITE 140
GOLDEN,  CO  80401
Correspondent Contact NANCY SAUER
Regulation Number876.1500
Classification Product Code
OCT  
Subsequent Product Code
GCJ  
Date Received03/19/2012
Decision Date 05/11/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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