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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Restraint, Protective
510(k) Number K790172
Device Name BK-5098 TILT TABLE 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 Number880.6760
Classification Product Code
FMQ  
Date Received01/26/1979
Decision Date 02/27/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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