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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cylinder, Compressed Gas, And Valve
510(k) Number K132778
Device Name GRAB 'N GO PLUS, GRAB 'N GO DIGITAL
Applicant
Praxair Healthcare Services
62 Forest St., Suite 300
Marlborough,  MA  01752
Applicant Contact TINA WU, PH.D.
Correspondent
Praxair Healthcare Services
62 Forest St., Suite 300
Marlborough,  MA  01752
Correspondent Contact TINA WU, PH.D.
Regulation Number868.2700
Classification Product Code
ECX  
Date Received09/05/2013
Decision Date 07/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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