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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barium Enema Kit
510(k) Number K934585
Device Name PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROL
Applicant
Lafayette Pharmaceuticals, Inc.
522 N. Earl Ave.
P.O. Box 4499
Lafayette,  IN  47903
Applicant Contact ROBERT A SHARP
Correspondent
Lafayette Pharmaceuticals, Inc.
522 N. Earl Ave.
P.O. Box 4499
Lafayette,  IN  47903
Correspondent Contact ROBERT A SHARP
Regulation Number876.5210
Classification Product Code
FCD  
Date Received09/23/1993
Decision Date 11/03/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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