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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 K050131
Device Name INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE
Applicant
M.K. MEDITECH CO. LTD.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact ROSINA ROBINSON
Correspondent
M.K. MEDITECH CO. LTD.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact ROSINA ROBINSON
Regulation Number880.5860
Classification Product Code
MEG  
Date Received01/21/2005
Decision Date 04/05/2005
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
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