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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 K931277
Device Name HOLLISTER PREMIUM URINE COLLECTOR
Applicant
HOLLISTER, INC.
2000 HOLLISTER DR.
LIBERTYVILLE,  IL  60048
Applicant Contact JOSEPH TOKARZ
Correspondent
HOLLISTER, INC.
2000 HOLLISTER DR.
LIBERTYVILLE,  IL  60048
Correspondent Contact JOSEPH TOKARZ
Regulation Number876.5250
Classification Product Code
EXI  
Date Received03/08/1993
Decision Date 06/23/1993
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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