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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K881981
Device Name ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM
Applicant
Ryder Intl. Corp.
3240 N. Indianapolis Rd.
P.O. Box 448
Columbus,  IN  47202
Applicant Contact ANTHONY J MORAVEC
Correspondent
Ryder Intl. Corp.
3240 N. Indianapolis Rd.
P.O. Box 448
Columbus,  IN  47202
Correspondent Contact ANTHONY J MORAVEC
Regulation Number876.5130
Classification Product Code
KOD  
Date Received05/12/1988
Decision Date 08/02/1988
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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