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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name syringe, piston
510(k) Number K895203
Device Name EN-TRAP SYRINGE
Original Applicant
THE MEDTECH GROUP, INC.
six century rd.
south planifield,  NJ  07080
Original Contact laurence g wesser
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/18/1989
Decision Date 10/18/1989
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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