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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conserver, Oxygen
510(k) Number K955129
Device Name OXYPULSE EOC I, EOC II & EOC R
Applicant
Eagle Medical Equipment Co.
3134 W. Lewis #30
Phx,  AZ  85017
Applicant Contact LAWRENCE PELLERITO
Correspondent
Eagle Medical Equipment Co.
3134 W. Lewis #30
Phx,  AZ  85017
Correspondent Contact LAWRENCE PELLERITO
Regulation Number868.5905
Classification Product Code
NFB  
Date Received11/09/1995
Decision Date 02/16/1996
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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