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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, paste-on for incontinence, sterile
510(k) Number K963950
Device Name BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE
Applicant
BIODERM, INC.
29 AINSWORTH AVE.
EAST BRUNSWICK,  NJ  08816
Applicant Contact ERIC FLAM
Correspondent
BIODERM, INC.
29 AINSWORTH AVE.
EAST BRUNSWICK,  NJ  08816
Correspondent Contact ERIC FLAM
Regulation Number876.5250
Classification Product Code
EXI  
Date Received10/02/1996
Decision Date 01/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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