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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 K994253
Device Name VACLOK SYRINGE
Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 WEST MERIT PKWY.
SOUTH JORDAN,  UT  84095
Applicant Contact CHESTER MCCOY
Correspondent
MERIT MEDICAL SYSTEMS, INC.
1600 WEST MERIT PKWY.
SOUTH JORDAN,  UT  84095
Correspondent Contact CHESTER MCCOY
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/17/1999
Decision Date 01/05/2000
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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