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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 K911971
Device Name MODIFIED SINGLE PATIENT USE DISP. MANUAL RESUSCIT.
Applicant
Puritan Bennett Corp.
9401 Indian Creek Pkwy.
P.O. Box 25905
Overland Park,  KS  66225
Applicant Contact MARSHALL SMITH
Correspondent
Puritan Bennett Corp.
9401 Indian Creek Pkwy.
P.O. Box 25905
Overland Park,  KS  66225
Correspondent Contact MARSHALL SMITH
Regulation Number868.5915
Classification Product Code
BTM  
Date Received05/03/1991
Decision Date 08/09/1991
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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