FDA 510(k) Application Details - K101145

Device Classification Name	Lancet, Blood   More FDA Info for this Device
510(K) Number	K101145
Device Name	Lancet, Blood
Applicant	MEDIPURPOSE PTE. LTD. 111 LAUREL RIDGE DRIVE ALPHARETTA, GA 30004 US Other 510(k) Applications for this Company
Contact	JULIE STEPHENS Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	FMK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2010
Decision Date	10/21/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review