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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
510(k) Number K851245
Device Name ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY
Applicant
Applinc
7677 Ronson Rd. Suite 108
San Diego,  CA  92102
Applicant Contact ERNESTO R AVILES
Correspondent
Applinc
7677 Ronson Rd. Suite 108
San Diego,  CA  92102
Correspondent Contact ERNESTO R AVILES
Regulation Number868.5270
Classification Product Code
BZE  
Date Received03/27/1985
Decision Date 05/15/1985
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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