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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K063454
Device Name POGS, MODEL 33C
Applicant
ON SITE GAS SYSTEMS, INC.
35 BUDNEY RD.
NEWINGTON,  CT  06111
Applicant Contact GUY HATCH
Correspondent
ON SITE GAS SYSTEMS, INC.
35 BUDNEY RD.
NEWINGTON,  CT  06111
Correspondent Contact GUY HATCH
Regulation Number868.5440
Classification Product Code
CAW  
Date Received11/15/2006
Decision Date 05/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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