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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enema Kit
510(k) Number K931896
Device Name PRO-FLO SYSTEM
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 Number876.5210
Classification Product Code
FCE  
Subsequent Product Code
JAA  
Date Received04/15/1993
Decision Date 08/26/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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