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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name attachment, breathing, positive end expiratory pressure
510(k) Number K932799
Device Name SINGLE USE MANUAL RESUSCITATOR PEEP VALVE
Applicant
ENGINEERED MEDICAL SYSTEMS
8529 ZIONSVILLE RD.
P.O. BOX 681514
INDIANAPOLIS,  IN  46268
Applicant Contact JEFF QUINN
Correspondent
ENGINEERED MEDICAL SYSTEMS
8529 ZIONSVILLE RD.
P.O. BOX 681514
INDIANAPOLIS,  IN  46268
Correspondent Contact JEFF QUINN
Regulation Number868.5965
Classification Product Code
BYE  
Date Received06/09/1993
Decision Date 09/03/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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