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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 K041664
Device Name PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C
Applicant
On Site Gas Systems, Inc.
35 Budney Rd.
Budney Industrial Park
Newington,,  CT  06111
Applicant Contact C. BART GULLONG
Correspondent
On Site Gas Systems, Inc.
35 Budney Rd.
Budney Industrial Park
Newington,,  CT  06111
Correspondent Contact C. BART GULLONG
Regulation Number868.5440
Classification Product Code
CAW  
Date Received06/18/2004
Decision Date 07/29/2004
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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