FDA 510(k) Application Details - K031649

Device Classification Name Chamber, Hyperbaric

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510(K) Number K031649
Device Name Chamber, Hyperbaric
Applicant FINK ENGINEERING PTY LTD
18111 COPPER RIDGE DRIVE
SAN ANTONIO, TX 78259 US
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Contact W.T. WORKMAN
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Regulation Number 868.5470

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Classification Product Code CBF
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Date Received 05/28/2003
Decision Date 12/05/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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