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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Hand, And Components
510(k) Number K790182
Device Name 2 VELCRO SPLINT STRAP
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 Number890.3475
Classification Product Code
ILH  
Date Received01/26/1979
Decision Date 02/15/1979
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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