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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 K022753
Device Name REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
Applicant
Medical Device Services
144 W. Brigham Rd.
Bldg. E
St. George,  UT  84790
Applicant Contact MARK ALDANA
Correspondent
Medical Device Services
144 W. Brigham Rd.
Bldg. E
St. George,  UT  84790
Correspondent Contact MARK ALDANA
Regulation Number870.5800
Classification Product Code
JOW  
Date Received08/19/2002
Decision Date 11/14/2002
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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