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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name garment, protective, for incontinence
510(k) Number K781930
Device Name PANT LINER, DISP. INCONTINENT
Applicant
FIBRE FORMATIONS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
FIBRE FORMATIONS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received11/15/1978
Decision Date 02/01/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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