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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 K900104
Device Name TCPM II TOURNIQUET CUFF PRESSURE MONITOR
Applicant
ELECTROMEDICS, INC.
P.O. BOX 3315
ENGLEWOOD,  CO  80155
Applicant Contact HAROLD W BRYAN
Correspondent
ELECTROMEDICS, INC.
P.O. BOX 3315
ENGLEWOOD,  CO  80155
Correspondent Contact HAROLD W BRYAN
Regulation Number878.5910
Classification Product Code
KCY  
Date Received01/09/1990
Decision Date 03/15/1990
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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