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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Gastro-Enterostomy
510(k) Number K860441
Device Name ENTROKIT WITH MAGLINTE 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
KGC  
Date Received02/04/1986
Decision Date 03/12/1986
Decision Substantially Equivalent - With Drug (SESD)
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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