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FDA 510(k) Application Details - K220014
Device Classification Name
More FDA Info for this Device
510(K) Number
K220014
Device Name
RSHOCK
Applicant
SWIMS America Corp
1133 Westchester Avenue Suite N 220
White Plains, NY 10604 US
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Contact
Matthieu Commeau
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Regulation Number
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Classification Product Code
PBX
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More FDA Info for this Product Code
Date Received
01/05/2022
Decision Date
03/01/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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