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FDA 510(k) Application Details - K182163
Device Classification Name
Stimulator, Muscle, Powered
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510(K) Number
K182163
Device Name
Stimulator, Muscle, Powered
Applicant
Shear Stress Therapeutics, LLC
6207 East 78th Place
Tulsa, OK 74136 US
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Contact
John Owen
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
08/10/2018
Decision Date
07/09/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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