FDA 510(k) Application Details - K020329

Device Classification Name Conserver, Oxygen

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510(K) Number K020329
Device Name Conserver, Oxygen
Applicant SUNRISE MEDICAL HHG, INC.
100 DEVILBISS DR.
SOMERSET, PA 15501 US
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Contact BRIAN HERSHEY
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Regulation Number 868.5905

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Classification Product Code NFB
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Date Received 01/31/2002
Decision Date 06/19/2002
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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