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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Ostomy
510(k) Number K791525
Device Name HOLLISTER KARAYA PASTE
Applicant
HOLLISTER, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
HOLLISTER, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5900
Classification Product Code
EXB  
Date Received08/10/1979
Decision Date 10/26/1979
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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