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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Non-Implantable, For Incontinence
510(k) Number K874867
Device Name CATR(TM)-H CARDIOTOMY HOLDER
Applicant
Bentley Laboratories, Inc.
17502 Armstrong Ave.
P.O. Box 19522
Irvine,  CA  92713
Applicant Contact MERRITT GIRGIS
Correspondent
Bentley Laboratories, Inc.
17502 Armstrong Ave.
P.O. Box 19522
Irvine,  CA  92713
Correspondent Contact MERRITT GIRGIS
Regulation Number876.5320
Classification Product Code
KPI  
Date Received11/27/1987
Decision Date 02/02/1988
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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