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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheters, suction, tracheobronchial
510(k) Number K902093
Device Name RESU-GARD CATHETER SUCTION
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 Number868.6810
Classification Product Code
BSY  
Date Received05/09/1990
Decision Date 10/23/1990
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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