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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 K945167
Device Name DJ MEDICAL PNEUMATIC TOURNIQUET
Applicant
DJ MEDICAL, INC.
11221 FANWOOD COURT
RICHMOND,  VA  23233
Applicant Contact STEPHEN J LEIBOVIC
Correspondent
DJ MEDICAL, INC.
11221 FANWOOD COURT
RICHMOND,  VA  23233
Correspondent Contact STEPHEN J LEIBOVIC
Regulation Number878.5910
Classification Product Code
KCY  
Date Received09/22/1994
Decision Date 02/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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