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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 Cedex,  FR 54601
Applicant Contact MOUSTAFA ANKI
Correspondent
Nellcor Puritan Bennett France Dvpt.
10 Allee Pelletier Doisy
Villers-Les-Nancy Cedex,  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
Predetermined Change
Control Plan Authorized		 No
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