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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Pump, Infusion
510(k) Number K132618
Device Name ONETOUCH REVEAL
Applicant
Lifescan, Inc.
965 Chesterbrook Blvd.
Wayne,  PA  19087
Applicant Contact GABRIELLE LOGAN
Correspondent
Lifescan, Inc.
965 Chesterbrook Blvd.
Wayne,  PA  19087
Correspondent Contact GABRIELLE LOGAN
Regulation Number880.5725
Classification Product Code
MRZ  
Subsequent Product Code
NBW  
Date Received08/21/2013
Decision Date 12/16/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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