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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 K811542
Device Name MGN SUCTION CATHETER
Applicant
MGN MEDICAL MANUFACTURING, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MGN MEDICAL MANUFACTURING, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.6810
Classification Product Code
BSY  
Date Received06/01/1981
Decision Date 06/18/1981
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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