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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 K912620
Device Name OPOMAT MANUAL RESUSCITATOR VENTILATOR
Applicant
Euro-Am Pharma, Inc.
64 Montrose Ave.
Fanwood,  NJ  07023
Applicant Contact NANIK D GYAN
Correspondent
Euro-Am Pharma, Inc.
64 Montrose Ave.
Fanwood,  NJ  07023
Correspondent Contact NANIK D GYAN
Regulation Number868.5915
Classification Product Code
BTM  
Date Received06/13/1991
Decision Date 12/04/1991
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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