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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 K014078
Device Name ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM
Applicant
ON SITE GAS SYSTEMS, INC.
100 PRODUCTION COURT
NEW BRITAIN,  CT  06051
Applicant Contact C. BARTON GULLONG
Correspondent
ON SITE GAS SYSTEMS, INC.
100 PRODUCTION COURT
NEW BRITAIN,  CT  06051
Correspondent Contact C. BARTON GULLONG
Regulation Number868.5440
Classification Product Code
CAW  
Date Received12/11/2001
Decision Date 01/08/2002
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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