FDA 510(k) Application Details - K011866

Device Classification Name Chamber, Hyperbaric

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510(K) Number K011866
Device Name Chamber, Hyperbaric
Applicant HYPERBARIC TECHNOLOGIES, INC.
3224 HOOVER AVE.
NATIONAL CITY, CA 91950 US
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Contact DAVE HEANEY
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Regulation Number 868.5470

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Classification Product Code CBF
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Date Received 06/14/2001
Decision Date 06/06/2002
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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