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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tourniquet, pneumatic
510(k) Number K112874
Device Name EZ VEIN INFLATABLE TOURNIQUET
Applicant
DOMINION MEDICAL DEVICES, LLC
P.O. BOX 560
STILLWATER,  MN  55082
Applicant Contact ELAINE DUNCAN
Correspondent
DOMINION MEDICAL DEVICES, LLC
P.O. BOX 560
STILLWATER,  MN  55082
Correspondent Contact ELAINE DUNCAN
Regulation Number878.5910
Classification Product Code
KCY  
Date Received09/30/2011
Decision Date 10/17/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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