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FDA 510(k) Application Details - K011565
Device Classification Name
Chamber, Hyperbaric
More FDA Info for this Device
510(K) Number
K011565
Device Name
Chamber, Hyperbaric
Applicant
GULF COAST HYPERBARICS, INC.
4309 GREEN LEAF CIRCLE
PANAMA CITY, FL 32404 US
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Contact
JAMES W MCCARTHY
Other 510(k) Applications for this Contact
Regulation Number
868.5470
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Classification Product Code
CBF
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More FDA Info for this Product Code
Date Received
05/21/2001
Decision Date
08/16/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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