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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 K111734
Device Name MYSAFETY SYRINGE
Applicant
Medicalchain Intl. Corp.
1808 Seabreeze Count,
Thousand Oaks,  CA  91320
Applicant Contact ROBIN HWANG
Correspondent
Medicalchain Intl. Corp.
1808 Seabreeze Count,
Thousand Oaks,  CA  91320
Correspondent Contact ROBIN HWANG
Regulation Number880.5860
Classification Product Code
MEG  
Date Received06/21/2011
Decision Date 09/06/2011
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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