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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 K862194
Device Name INHALATOR MODELS 8100, 10100 AND 10200
Applicant
U.O. Equipment Co.
P.O. Box 500386
Houston,  TX  77250
Applicant Contact WRIGHT
Correspondent
U.O. Equipment Co.
P.O. Box 500386
Houston,  TX  77250
Correspondent Contact WRIGHT
Regulation Number868.5440
Classification Product Code
CAW  
Date Received06/09/1986
Decision Date 07/28/1986
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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