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FDA 510(k) Application Details - K163067
Device Classification Name
Stimulator, Muscle, Powered
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510(K) Number
K163067
Device Name
Stimulator, Muscle, Powered
Applicant
CyMedica Orthopedics, Inc.
19120 N. Pima Rd.
Suite 135
Scottsdale, AZ 85255 US
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Contact
Kereshmeh Shahriari
Other 510(k) Applications for this Contact
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
11/02/2016
Decision Date
12/01/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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