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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 K001845
Device Name MALLINCKRODT, GOODKNIGHT 418S
Applicant
Mallinckrodt Developpement France
10 Allee Pelletier Doisy
Villers-Les-Nancy Cedex,  FR 54601
Applicant Contact MOUSTAFA ANKI
Correspondent
Mallinckrodt Developpement France
10 Allee Pelletier Doisy
Villers-Les-Nancy Cedex,  FR 54601
Correspondent Contact MOUSTAFA ANKI
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/19/2000
Decision Date 07/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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