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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peritoneal, Long-Term Indwelling
510(k) Number K885167
Device Name TRUDELL BENT CATHETER
Applicant
Sil-Med Corp.
700 Warner Blvd.
Taunton,  MA  02780
Applicant Contact S MCCALLUM
Correspondent
Sil-Med Corp.
700 Warner Blvd.
Taunton,  MA  02780
Correspondent Contact S MCCALLUM
Regulation Number876.5630
Classification Product Code
FJS  
Date Received12/13/1988
Decision Date 01/31/1989
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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