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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K031189
Device Name UUHC REPROCESSED COMPRESSION SLEEVE DEVICES
Applicant
University of Utah Hospitals and Clinics
1800 E. 900 S.
Salt Lake City,  UT  84108
Applicant Contact JACK SPEER
Correspondent
University of Utah Hospitals and Clinics
1800 E. 900 S.
Salt Lake City,  UT  84108
Correspondent Contact JACK SPEER
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/15/2003
Decision Date 10/16/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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