FDA 510(k) Application Details - K022214

Device Classification Name Chamber, Hyperbaric

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510(K) Number K022214
Device Name Chamber, Hyperbaric
Applicant MECHIDYNE SYSTEMS, INC.
P.O. BOX 840661
HOUSTON, TX 77284-0661 US
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Contact AUDREY L AARON
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Regulation Number 868.5470

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Classification Product Code CBF
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Date Received 07/08/2002
Decision Date 02/26/2003
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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