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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 K060208
Device Name CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,
Applicant
Life-Shield Products, Inc.
3f, No 10, Wuchiuan 7th Rd.
Wugu Industrial Park
Taipei,  TW 248
Applicant Contact CHAO-HUA SHIH
Correspondent
Life-Shield Products, Inc.
3f, No 10, Wuchiuan 7th Rd.
Wugu Industrial Park
Taipei,  TW 248
Correspondent Contact CHAO-HUA SHIH
Regulation Number880.5860
Classification Product Code
MEG  
Date Received01/27/2006
Decision Date 03/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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