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FDA 510(k) Application Details - K011134
Device Classification Name
Tubing, Pressure And Accessories
More FDA Info for this Device
510(K) Number
K011134
Device Name
Tubing, Pressure And Accessories
Applicant
HUDSON RESPIRATORY CARE, INC.
27711 DIAZ RD.
P.O. BOX 9020
TEMECULA, CA 92589-9020 US
Other 510(k) Applications for this Company
Contact
JEANNIE K DENNING
Other 510(k) Applications for this Contact
Regulation Number
868.5860
More FDA Info for this Regulation Number
Classification Product Code
BYX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/13/2001
Decision Date
06/13/2001
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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