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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Components, Exercise
510(k) Number K831544
Device Name DELUXE TRACTION EXERCISE GLOVE BK5035
Applicant
Fred Sammons, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Fred Sammons, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5350
Classification Product Code
IOD  
Date Received05/12/1983
Decision Date 06/24/1983
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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