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FDA 510(k) Application Details - K020329
Device Classification Name
Conserver, Oxygen
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
868.5905
More FDA Info for this Regulation Number
Classification Product Code
NFB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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