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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
Applicant
The Medtech Group, Inc.
Six Century Rd.
South Planifield,  NJ  07080
Applicant Contact LAURENCE G WESSER
Correspondent
The Medtech Group, Inc.
Six Century Rd.
South Planifield,  NJ  07080
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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