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FDA 510(k) Application Details - K060265
Device Classification Name
Regulator, Pressure, Gas Cylinder
More FDA Info for this Device
510(K) Number
K060265
Device Name
Regulator, Pressure, Gas Cylinder
Applicant
REMCORE, INC.
14 BOND STREET
BOSTON, MA 02118 US
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Contact
KEVIN JORCZAK
Other 510(k) Applications for this Contact
Regulation Number
868.2700
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Classification Product Code
CAN
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More FDA Info for this Product Code
Date Received
02/01/2006
Decision Date
10/25/2006
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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