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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Utensil, Eating
510(k) Number K800019
Device Name BK-1544 BE OK SCOOP DISK
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 Number890.5050
Classification Product Code
ILC  
Date Received01/02/1980
Decision Date 01/21/1980
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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