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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nebulizer (direct patient interface)
510(k) Number K990897
Device Name NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER
Applicant
PURITAN-BENNETT IRELAND, LTD.
MERVUE
GALWAY,  IE
Applicant Contact ROBBIE WALSH
Correspondent
PURITAN-BENNETT IRELAND, LTD.
MERVUE
GALWAY,  IE
Correspondent Contact ROBBIE WALSH
Regulation Number868.5630
Classification Product Code
CAF  
Subsequent Product Code
CBK  
Date Received03/18/1999
Decision Date 03/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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