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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electromyograph, diagnostic
510(k) Number K842649
Device Name BATH TUB TRANSFER CHAIR
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 Number890.1375
Classification Product Code
IKN  
Date Received07/10/1984
Decision Date 08/10/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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