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FDA 510(k) Application Details - K133210
Device Classification Name
Attachment, Breathing, Positive End Expiratory Pressure
More FDA Info for this Device
510(K) Number
K133210
Device Name
Attachment, Breathing, Positive End Expiratory Pressure
Applicant
S & T MEDICAL TECHNOLOGIES, INC.
1954 KELLOGG AVENUE
SUITE 100
CARLSBAD, CA 92008 US
Other 510(k) Applications for this Company
Contact
DERICK CORRENTE
Other 510(k) Applications for this Contact
Regulation Number
868.5965
More FDA Info for this Regulation Number
Classification Product Code
BYE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/17/2013
Decision Date
03/28/2014
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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