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FDA 510(k) Application Details - K213655
Device Classification Name
Stimulator, Muscle, Powered
More FDA Info for this Device
510(K) Number
K213655
Device Name
Stimulator, Muscle, Powered
Applicant
HillTek LLC
421 S Brookhurst Street; Ste#142
Anaheim, CA 92804 US
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Contact
Mohammadali Nezakati
Other 510(k) Applications for this Contact
Regulation Number
890.5850
More FDA Info for this Regulation Number
Classification Product Code
IPF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/19/2021
Decision Date
01/17/2023
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
N
Expedited Review
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