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FDA 510(k) Application Details - K202979
Device Classification Name
Exerciser, Measuring
More FDA Info for this Device
510(K) Number
K202979
Device Name
Exerciser, Measuring
Applicant
Lode B.V.
Zernikepark 16
Groningen 9747 AN NL
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Contact
J.R. Fransens
Other 510(k) Applications for this Contact
Regulation Number
890.5360
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Classification Product Code
ISD
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More FDA Info for this Product Code
Date Received
09/30/2020
Decision Date
12/21/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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