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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
510(k) Number K130132
Device Name BABYLANCE HEEL INCISION DEVICE
Applicant
Medipurpose Pte. , Ltd.
111 Laurel Ridge Dr.
Alpharetta,  GA  30004
Applicant Contact JULIE STEPHENS
Correspondent
Medipurpose Pte. , Ltd.
111 Laurel Ridge Dr.
Alpharetta,  GA  30004
Correspondent Contact JULIE STEPHENS
Regulation Number878.4850
Classification Product Code
FMK  
Date Received01/18/2013
Decision Date 02/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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