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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 K052397
Device Name CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML)
Applicant
Life-Shield Products, Inc.
3f, No 10, Wuchiuan 7th Rd.
Wugu Industrial Park
Taipei,  TW 248
Applicant Contact Ke-Min Jen
Correspondent
Life-Shield Products, Inc.
3f, No 10, Wuchiuan 7th Rd.
Wugu Industrial Park
Taipei,  TW 248
Correspondent Contact Ke-Min Jen
Regulation Number880.5860
Classification Product Code
MEG  
Date Received08/31/2005
Decision Date 12/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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