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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K061055
Device Name CAREO SAFETY SYRINGE FOR U-100 INSULIN
Applicant
LIFE-SHIELD PRODUCTS, INC
3F, NO 10, WUCHIUAN 7TH RD
WUGU INDUSTRIAL PARK
TAIPEI,  TW 248
Applicant Contact CHUNG-CHIH HSIAO
Correspondent
LIFE-SHIELD PRODUCTS, INC
3F, NO 10, WUCHIUAN 7TH RD
WUGU INDUSTRIAL PARK
TAIPEI,  TW 248
Correspondent Contact CHUNG-CHIH HSIAO
Regulation Number880.5860
Classification Product Code
MEG  
Date Received04/17/2006
Decision Date 07/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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