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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 K003455
Device Name MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
Applicant
Chad Therapeutics, Inc.
21622 Plummer St.
Chatsworth,  CA  91311
Applicant Contact KEVIN MCCULLOH
Correspondent
Chad Therapeutics, Inc.
21622 Plummer St.
Chatsworth,  CA  91311
Correspondent Contact KEVIN MCCULLOH
Regulation Number868.5905
Classification Product Code
NFB  
Date Received11/07/2000
Decision Date 12/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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