FDA 510(k) Application Details - K981938

Device Classification Name Chamber, Hyperbaric

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510(K) Number K981938
Device Name Chamber, Hyperbaric
Applicant TAMPA HYPERBARIC ENT.
700 WEST WATERS AVE.
TAMPA, FL 33604 US
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Contact MICHAEL CAPRIA
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Regulation Number 868.5470

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Classification Product Code CBF
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Date Received 06/02/1998
Decision Date 07/06/1999
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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