FDA 510(k) Application Details - K030713

Device Classification Name Chamber, Hyperbaric

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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
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Regulation Number 868.5470

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Classification Product Code CBF
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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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