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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 K844223
Device Name PREMIER O2 OXYGEN CONCENTRATOR
Applicant
Everest & Jennings, Inc.
3233 E Mission Oaks Blvd.
Camarillo,  CA  93010
Applicant Contact KEN MOLINELLI
Correspondent
Everest & Jennings, Inc.
3233 E Mission Oaks Blvd.
Camarillo,  CA  93010
Correspondent Contact KEN MOLINELLI
Regulation Number868.5440
Classification Product Code
CAW  
Date Received11/01/1984
Decision Date 12/24/1984
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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