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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vaporizer, Anesthesia, Non-Heated
510(k) Number K041076
Device Name DELTA T
Applicant
Penlon , Ltd.
Barton Lane
Abingdon,  GB OX14 3PH
Applicant Contact ALAN GREEN
Correspondent
Penlon , Ltd.
Barton Lane
Abingdon,  GB OX14 3PH
Correspondent Contact ALAN GREEN
Regulation Number868.5880
Classification Product Code
CAD  
Date Received04/26/2004
Decision Date 08/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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