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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Hot Or Cold, Water Circulating
510(k) Number K801301
Device Name GOLDEN THERMAL RHINOPLASTY CAST BANDAGE
Applicant
Auric, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Auric, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5720
Classification Product Code
ILO  
Date Received06/03/1980
Decision Date 06/20/1980
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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