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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gas-machine, anesthesia
510(k) Number K061102
Device Name PRIMA ANAESTHESIA MACHINE
Applicant
PENLON LTD.
Abingdon Science Park
Barton Lane, Abingdon,  GB OX14 3NB
Applicant Contact BARRY PEARCE
Correspondent
PENLON LTD.
Abingdon Science Park
Barton Lane, Abingdon,  GB OX14 3NB
Correspondent Contact BARRY PEARCE
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received04/19/2006
Decision Date 07/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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