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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stocking, Elastic
510(k) Number K780547
Device Name STERILE ORTHOPEDIC STOCKINETTE
Applicant
Alba-Waldensian, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Alba-Waldensian, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3475
Classification Product Code
ILG  
Date Received04/05/1978
Decision Date 04/10/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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