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FDA 510(k) Application Details - K001409
Device Classification Name
Chamber, Hyperbaric
More FDA Info for this Device
510(K) Number
K001409
Device Name
Chamber, Hyperbaric
Applicant
HYPERBARIC TECHNOLOGIES, INC.
6329 W. WATERVIEW CT.
MCCORDSVILLE, IN 46055-9501 US
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Contact
PAUL E DRYDEN
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
05/04/2000
Decision Date
08/02/2000
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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