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FDA 510(k) Application Details - K970443
Device Classification Name
Device, Paste-On For Incontinence, Sterile
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510(K) Number
K970443
Device Name
Device, Paste-On For Incontinence, Sterile
Applicant
HOLLISTER, INC.
2000 HOLLISTER DR.
LIBERTYVILLE, IL 60048 US
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Contact
JOSEPH S TOKARZ
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Regulation Number
876.5250
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Classification Product Code
EXI
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More FDA Info for this Product Code
Date Received
02/05/1997
Decision Date
02/25/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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