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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Urine, (And Accessories) For Indwelling Catheter
510(k) Number K862934
Device Name HOLLISTER FEMALE URINARY COLLECTION POUCH
Applicant
Hollister, Inc.
2000 Hollister Dr.
Libertyville,  IL  60048
Applicant Contact JEROME A SAXON
Correspondent
Hollister, Inc.
2000 Hollister Dr.
Libertyville,  IL  60048
Correspondent Contact JEROME A SAXON
Regulation Number876.5250
Classification Product Code
KNX  
Date Received08/04/1986
Decision Date 08/19/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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