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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 Dr. At 31st St.
Chicago,  IL  60616
Applicant Contact LEVY, M.D.
Correspondent
Michael Reese Hospital and Medical Center
Dept. Of Ob-Gyn
Lake Shore Dr. 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
Predetermined Change
Control Plan Authorized		 No
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