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FDA 510(k) Application Details - K181497
Device Classification Name
Stimulator, Electrical, Non-Implantable, For Incontinence
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510(K) Number
K181497
Device Name
Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant
BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752 US
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Contact
David Chmel
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Regulation Number
876.5320
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Classification Product Code
KPI
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More FDA Info for this Product Code
Date Received
06/07/2018
Decision Date
11/14/2018
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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