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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 K880044
Device Name OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8
Applicant
Oxygen Enrichment Company, Ltd.
1900 Maxon Rd.
P.O. Box 1025
Schenectady,  NY  12308
Applicant Contact JAMES C HUSSEY
Correspondent
Oxygen Enrichment Company, Ltd.
1900 Maxon Rd.
P.O. Box 1025
Schenectady,  NY  12308
Correspondent Contact JAMES C HUSSEY
Regulation Number868.5440
Classification Product Code
CAW  
Date Received01/06/1988
Decision Date 03/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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