FDA 510(k) Application Details - K991722

Device Classification Name Generator, Oxygen, Portable

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510(K) Number K991722
Device Name Generator, Oxygen, Portable
Applicant SUNRISE MEDICAL HHG, INC.
100 DEVILBISS DR.
SOMERSET, PA 15501 US
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Contact GREG CLITES
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Regulation Number 868.5440

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Classification Product Code CAW
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Date Received 05/20/1999
Decision Date 11/03/1999
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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