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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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