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FDA 510(k) Application Details - K030713
Device Classification Name
Chamber, Hyperbaric
More FDA Info for this Device
510(K) Number
K030713
Device Name
Chamber, Hyperbaric
Applicant
BAY AREA HYPERSCIENCES, LLC
18213 SANDY COVE
HOUSTON, TX 77058 US
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Contact
EDWARD F GOOD
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
03/06/2003
Decision Date
12/19/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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