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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing And Support, Ventilator (W Harness)
510(k) Number K823479
Device Name MODUFLEX NEONATAL VENTILATOR SET
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Regulation Number868.5975
Classification Product Code
BZO  
Date Received11/23/1982
Decision Date 12/15/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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