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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Double Lumen For Intestinal Decompression And/Or Intubation
510(k) Number K772282
Device Name HODGE TUBE
Applicant
MALLINCKRODT CRITICAL CARE
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MALLINCKRODT CRITICAL CARE
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5980
Classification Product Code
FEG  
Date Received12/12/1977
Decision Date 03/09/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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