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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 K971889
Device Name CHAD TOTAL O2 DELIVERY SYSTEM
Applicant
Chad Therapeutics, Inc.
21622 Plummer St.
Chatsworth,  CA  91311
Applicant Contact LOUIE GORYOKA
Correspondent
Chad Therapeutics, Inc.
21622 Plummer St.
Chatsworth,  CA  91311
Correspondent Contact LOUIE GORYOKA
Regulation Number868.5440
Classification Product Code
CAW  
Date Received05/21/1997
Decision Date 11/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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