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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 K022806
Device Name DUOPRO SAFETY SYRINGE (DUOPROSS)
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  
Subsequent Product Code
FMI  
Date Received08/23/2002
Decision Date 09/19/2002
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
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