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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 K903342
Device Name DEODORIZING AND SOUND MUFFLING ANAL PAD
Applicant
BIOLOGICAL RESISTANCE, INC.
70 ROPER RD.
PRINCETON,  NJ  08540
Applicant Contact ALEXANDER YABROV
Correspondent
BIOLOGICAL RESISTANCE, INC.
70 ROPER RD.
PRINCETON,  NJ  08540
Correspondent Contact ALEXANDER YABROV
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received07/25/1990
Decision Date 10/23/1990
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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