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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mammographic
510(k) Number K884917
Device Name RESUSCITATOR'S GUARD SUCTION CONTROL SYSTEM
Applicant
Amg Medical Equipments, Inc.
743 Michigan Ln.
Elk Grove,  IL  60007
Applicant Contact GAJO, M.D.
Correspondent
Amg Medical Equipments, Inc.
743 Michigan Ln.
Elk Grove,  IL  60007
Correspondent Contact GAJO, M.D.
Regulation Number892.1710
Classification Product Code
IZH  
Date Received11/28/1988
Decision Date 03/09/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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