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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
Predetermined Change
Control Plan Authorized		 No
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