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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Gastrointestinal Motility (Electrical)
510(k) Number K881609
FOIA Releasable 510(k) K881609
Device Name SITZMARKS
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 Number876.1725
Classification Product Code
FFX  
Date Received04/12/1988
Decision Date 07/08/1988
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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