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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 K010819
Device Name 3CC NMT SAFETY SYRINGE
Applicant
New Medical Technology , Ltd.
1500 W. Oak St.
P.O. Box 317
Zionsville,  IN  46077
Applicant Contact MIKE MALANDRAKIS
Correspondent
New Medical Technology , Ltd.
1500 W. Oak St.
P.O. Box 317
Zionsville,  IN  46077
Correspondent Contact MIKE MALANDRAKIS
Regulation Number880.5860
Classification Product Code
MEG  
Date Received03/19/2001
Decision Date 11/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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