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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Regulator, Pressure, Gas Cylinder
510(k) Number K060265
Device Name REMCORE REMOTE CONTROLLED OXYGEN REGULATOR
Applicant
Remcore, Inc.
14 Bond St.
Boston,  MA  02118
Applicant Contact KEVIN JORCZAK
Correspondent
Remcore, Inc.
14 Bond St.
Boston,  MA  02118
Correspondent Contact KEVIN JORCZAK
Regulation Number868.2700
Classification Product Code
CAN  
Date Received02/01/2006
Decision Date 10/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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