FDA 510(k) Application Details - K982943

Device Classification Name Conserver, Oxygen

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510(K) Number K982943
Device Name Conserver, Oxygen
Applicant TRANSTRACHEAL SYSTEMS
4655 KIRKWOOD COURT
BOULDER, CO 80301 US
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Contact LEWIS W WARD
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Regulation Number 868.5905

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Classification Product Code NFB
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Date Received 08/21/1998
Decision Date 07/12/1999
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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