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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 K971499
Device Name FEMALE EXTERNAL URINARY COLLECTION POUCH
Applicant
MEDIQUEST, INC.
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Applicant Contact GREG HOLLAND
Correspondent
MEDIQUEST, INC.
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Correspondent Contact GREG HOLLAND
Regulation Number876.5250
Classification Product Code
EXI  
Subsequent Product Code
EYZ  
Date Received04/25/1997
Decision Date 08/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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