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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 K060382
Device Name FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1
Applicant
AMERIFLO CORP.
478 GRADLE DR.
CARMEL,  IN  46032
Applicant Contact MATTHEW THIE
Correspondent
AMERIFLO CORP.
478 GRADLE DR.
CARMEL,  IN  46032
Correspondent Contact MATTHEW THIE
Regulation Number868.5905
Classification Product Code
NFB  
Date Received02/14/2006
Decision Date 04/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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