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FDA 510(k) Application Details - K202286
Device Classification Name
More FDA Info for this Device
510(K) Number
K202286
Device Name
Tulsa-Pro System
Applicant
Profound Medical Inc
2400 Skymark Avenue, Unit 6
Mississauga L4W 5K5 CA
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Contact
Goldy Singh
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Regulation Number
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Classification Product Code
PLP
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Date Received
08/12/2020
Decision Date
09/16/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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