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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 K905002
Device Name SINGLE USE MANUAL RESUSCITATORS
Applicant
Custom Medical, Inc.
2002 W. Vernal Pike
Bloomington,  IN  47404
Applicant Contact GREGORY T POPP
Correspondent
Custom Medical, Inc.
2002 W. Vernal Pike
Bloomington,  IN  47404
Correspondent Contact GREGORY T POPP
Regulation Number868.5915
Classification Product Code
BTM  
Date Received11/07/1990
Decision Date 03/29/1991
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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