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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K984379
Device Name NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM
Applicant
PURITAN BENNETT CORP.
MERVUE
GALWAY,  IE
Applicant Contact ROBBIE WALSH
Correspondent
PURITAN BENNETT CORP.
MERVUE
GALWAY,  IE
Correspondent Contact ROBBIE WALSH
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/07/1998
Decision Date 12/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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