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FDA 510(k) Application Details - K210764
Device Classification Name
Perineometer
More FDA Info for this Device
510(K) Number
K210764
Device Name
Perineometer
Applicant
Pelvital USA, Inc.
1000 LaSalle Avenue, SCH 435
Minneapolis, MN 55403 US
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Contact
Dale Wahlstrom
Other 510(k) Applications for this Contact
Regulation Number
884.1425
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Classification Product Code
HIR
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More FDA Info for this Product Code
Date Received
03/15/2021
Decision Date
04/13/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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