FDA 510(k) Application Details - K951044

Device Classification Name Chamber, Hyperbaric

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510(K) Number K951044
Device Name Chamber, Hyperbaric
Applicant NTH SYSTEMS, INC.
1208 SAFARI
SAN ANTONIO, TX 78216 US
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Contact PAUL RENEAU
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Regulation Number 868.5470

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Classification Product Code CBF
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Date Received 03/07/1995
Decision Date 01/25/1996
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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