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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 K904639
Device Name GENOX MODEL CT-1
Applicant
Pacific Consolidated Industries
2340 N. Glassell St.
Orange,  CA  92665
Applicant Contact LEE W SMITH
Correspondent
Pacific Consolidated Industries
2340 N. Glassell St.
Orange,  CA  92665
Correspondent Contact LEE W SMITH
Regulation Number868.5440
Classification Product Code
CAW  
Date Received10/11/1990
Decision Date 08/13/1991
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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