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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention, Barium Enema With Bag
510(k) Number K884379
Device Name MAGLINTE ENTEROCLYSIS CATHETER
Applicant
Lafayette Pharmacal, Inc.
522 N. Earl Ave.
Lafayette,  IN  47903
Applicant Contact ROBERT A SHARP
Correspondent
Lafayette Pharmacal, Inc.
522 N. Earl Ave.
Lafayette,  IN  47903
Correspondent Contact ROBERT A SHARP
Regulation Number876.5980
Classification Product Code
FGD  
Date Received10/18/1988
Decision Date 02/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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