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FDA 510(k) Application Details - K181759
Device Classification Name
Stimulator, Muscle, Powered
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510(K) Number
K181759
Device Name
Stimulator, Muscle, Powered
Applicant
Smartmissimo Technologies Pte Ltd
#28-01, SGX Centre II, 4 Shenton Way
Singapore 068807 SG
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Contact
Alexey Pisarev
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Regulation Number
890.5850
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Classification Product Code
IPF
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More FDA Info for this Product Code
Date Received
07/02/2018
Decision Date
11/09/2018
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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