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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 K021082
Device Name ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0
Applicant
ON SITE GAS SYSTEMS, INC.
35 BUDNEY RD.
BUDNEY INDUSTRIAL PARK
NEWINGTON,,  CT  06111
Applicant Contact C. BARTON GULLONG
Correspondent
ON SITE GAS SYSTEMS, INC.
35 BUDNEY RD.
BUDNEY INDUSTRIAL PARK
NEWINGTON,,  CT  06111
Correspondent Contact C. BARTON GULLONG
Regulation Number868.5440
Classification Product Code
CAW  
Date Received04/03/2002
Decision Date 05/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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