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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cane
510(k) Number K790299
Device Name FOREARM-CANE
Applicant
Guardian Products Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Guardian Products Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3075
Classification Product Code
IPS  
Date Received02/12/1979
Decision Date 02/21/1979
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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