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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K991150
Device Name NELLCOR PURITAN BENNETT, GOODKNIGHT 418G
Applicant
NELLCOR PURITAN BENNETT FRANCE DVPT.
10 ALLEE PELLETIER DOISY
VILLERS-LES-NANCY,  FR 54601
Applicant Contact MOUSTAFA ANKI
Correspondent
NELLCOR PURITAN BENNETT FRANCE DVPT.
10 ALLEE PELLETIER DOISY
VILLERS-LES-NANCY,  FR 54601
Correspondent Contact MOUSTAFA ANKI
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/06/1999
Decision Date 04/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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