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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 K862181
Device Name MECONIUM SUCTION TRAP
Applicant
MICHAEL REESE HOSPITAL AND MEDICAL CENTER
DEPT. OF OB-GYN
LAKE SHORE DRIVE AT 31ST ST.
CHICAGO,  IL  60616
Applicant Contact LEVY, M.D.
Correspondent
MICHAEL REESE HOSPITAL AND MEDICAL CENTER
DEPT. OF OB-GYN
LAKE SHORE DRIVE AT 31ST ST.
CHICAGO,  IL  60616
Correspondent Contact LEVY, M.D.
Regulation Number868.6810
Classification Product Code
BSY  
Date Received06/09/1986
Decision Date 08/13/1986
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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