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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 K102452
Device Name DEFOGGING AND CLEANING SOLUTION- FLO-X
Applicant
Minimally Invasive Devices, LLC
6329 SW 81st Rd.
Lake Butler,  FL  32054
Applicant Contact MARK L FRIEDMAN, PH.D
Correspondent
Minimally Invasive Devices, LLC
6329 SW 81st Rd.
Lake Butler,  FL  32054
Correspondent Contact MARK L FRIEDMAN, PH.D
Regulation Number876.1500
Classification Product Code
OCT  
Date Received08/27/2010
Decision Date 12/23/2010
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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