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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name adaptor, hygiene
510(k) Number K761126
Device Name EXTRA LARGE LONG HANDLED SPONGE
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
ILS  
Date Received11/19/1976
Decision Date 12/02/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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