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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, emergency, manual (resuscitator)
510(k) Number K973419
Device Name DMR PLUS DISPOSABLE MANUAL RESUSCITATOR
Applicant
NELLCOR PURITAN BENNETT, INC.
4280 HACIENDA DR.
PLEASANTON,  CA  94588 -2719
Applicant Contact SHERYLL A MATHEWS
Correspondent
NELLCOR PURITAN BENNETT, INC.
4280 HACIENDA DR.
PLEASANTON,  CA  94588 -2719
Correspondent Contact SHERYLL A MATHEWS
Regulation Number868.5915
Classification Product Code
BTM  
Date Received09/10/1997
Decision Date 03/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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