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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 K033615
Device Name WFSI'S REPROCESSED COMPRESSION SLEEVE DEVICES
Applicant
WHEATON FRANCISCAN SERVICES INC., SUPPLY CHAIN
1800 EAST 900 SOUTH
SALT LAKE CITY,  UT  84108
Applicant Contact JACK SPEER
Correspondent
WHEATON FRANCISCAN SERVICES INC., SUPPLY CHAIN
1800 EAST 900 SOUTH
SALT LAKE CITY,  UT  84108
Correspondent Contact JACK SPEER
Regulation Number870.5800
Classification Product Code
JOW  
Date Received11/17/2003
Decision Date 02/13/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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