FDA 510(k) Application Details - K002794

Device Classification Name Chamber, Hyperbaric

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510(K) Number K002794
Device Name Chamber, Hyperbaric
Applicant HYPERTEC, INC.
PO BOX 7007
DEERFIELD, IL 60015 US
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Contact DANIEL KAMM
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Regulation Number 868.5470

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Classification Product Code CBF
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Date Received 09/07/2000
Decision Date 12/06/2000
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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