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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 K101417
Device Name BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200
Applicant
MEDIPURPOSE PTE. LTD.
111 LAUREL RIDGE DRIVE
ALPHARETTA,  GA  30004
Applicant Contact JULIE STEPHENS
Correspondent
MEDIPURPOSE PTE. LTD.
111 LAUREL RIDGE DRIVE
ALPHARETTA,  GA  30004
Correspondent Contact JULIE STEPHENS
Regulation Number878.4850
Classification Product Code
FMK  
Date Received05/20/2010
Decision Date 10/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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