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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 K961405
Device Name ALBA HEALTH PAS WRAP SYSTEM
Applicant
Alba-Waldensian, Inc.
201 St. Germain Ave., SW
Valdese,  NC  28690
Applicant Contact VICTOR H GARROU
Correspondent
Alba-Waldensian, Inc.
201 St. Germain Ave., SW
Valdese,  NC  28690
Correspondent Contact VICTOR H GARROU
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/11/1996
Decision Date 12/26/1996
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
Recalls CDRH Recalls
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