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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 K031470
Device Name PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US
Applicant
TYCO HEALTHCARE NANCY
NELLCOR PURITAN BENNETT DIV.
4280 HACIENDA DRIVE
PLEASANTON,  CA  94588
Applicant Contact JAMES BONDS
Correspondent
TYCO HEALTHCARE NANCY
NELLCOR PURITAN BENNETT DIV.
4280 HACIENDA DRIVE
PLEASANTON,  CA  94588
Correspondent Contact JAMES BONDS
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/09/2003
Decision Date 06/05/2003
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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