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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K123957
Device Name PNEUPAC PARAPAC PLUS
Applicant
Smiths Medical International , Ltd.
Bramingham Business Park
Enterprise Way
Luton, Bedfordshire,  GB LU3 4BU
Applicant Contact LORI BERENDS
Correspondent
Smiths Medical International , Ltd.
Bramingham Business Park
Enterprise Way
Luton, Bedfordshire,  GB LU3 4BU
Correspondent Contact LORI BERENDS
Regulation Number868.5925
Classification Product Code
BTL  
Subsequent Product Code
BYE  
Date Received12/21/2012
Decision Date 09/16/2013
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
Recalls CDRH Recalls
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