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FDA 510(k) Application Details - K220290
Device Classification Name
Chamber, Hyperbaric
More FDA Info for this Device
510(K) Number
K220290
Device Name
Chamber, Hyperbaric
Applicant
US Hyperbaric Network
7600 NW 69th Ave
Medley, FL 33166 US
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Contact
Jorge Millan
Other 510(k) Applications for this Contact
Regulation Number
868.5470
More FDA Info for this Regulation Number
Classification Product Code
CBF
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More FDA Info for this Product Code
Date Received
02/01/2022
Decision Date
05/04/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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