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FDA 510(k) Application Details - K061055
Device Classification Name
Syringe, Antistick
More FDA Info for this Device
510(K) Number
K061055
Device Name
Syringe, Antistick
Applicant
LIFE-SHIELD PRODUCTS, INC
3F, NO 10, WUCHIUAN 7TH RD
WUGU INDUSTRIAL PARK
TAIPEI 248 TW
Other 510(k) Applications for this Company
Contact
CHUNG-CHIH HSIAO
Other 510(k) Applications for this Contact
Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
MEG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/17/2006
Decision Date
07/10/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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