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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 K053564
Device Name KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454
Applicant
PENLON LIMITED
25 BARKER CLOSE
FISHBOURNE, CHICHESTER
WEST SUSSEX,  GB PO18 8BJ
Applicant Contact BARRY PEARCE
Correspondent
PENLON LIMITED
25 BARKER CLOSE
FISHBOURNE, CHICHESTER
WEST SUSSEX,  GB PO18 8BJ
Correspondent Contact BARRY PEARCE
Regulation Number868.5880
Classification Product Code
CAD  
Date Received12/22/2005
Decision Date 03/03/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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