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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 K961392
Device Name ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II
Applicant
SIL-MED CORP.
700 WARNER BLVD.
TAUNTON,  MA  02780
Applicant Contact KAREN K SYLVIA
Correspondent
SIL-MED CORP.
700 WARNER BLVD.
TAUNTON,  MA  02780
Correspondent Contact KAREN K SYLVIA
Regulation Number876.5630
Classification Product Code
FJS  
Date Received04/11/1996
Decision Date 07/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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