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FDA 510(k) Application Details - K974600
Device Classification Name
External Urethral Occluder, Urinary Incontinence-Control, Female
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510(K) Number
K974600
Device Name
External Urethral Occluder, Urinary Incontinence-Control, Female
Applicant
UROMED CORP.
64 A ST.
NEEDHAM, MA 02194 US
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Contact
FREDERICK TOBIA
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Regulation Number
876.5160
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Classification Product Code
MNG
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More FDA Info for this Product Code
Date Received
12/09/1997
Decision Date
03/31/1998
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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