FDA 510(k) Application Details - K990678

Device Classification Name Conserver, Oxygen

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510(K) Number K990678
Device Name Conserver, Oxygen
Applicant SALTER LABS
100 WEST SYCAMORE RD.
ARVIN, CA 93203 US
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Contact DUANE KAZAL
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Regulation Number 868.5905

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Classification Product Code NFB
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Date Received 03/02/1999
Decision Date 05/07/1999
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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