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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 dialysis, single use
510(k) Number K854966
Device Name ACUTE PERITONEAL DIALYSIS CATHETERS
Applicant
THERMEDICS, INC.
470 WILDWOOD ST.
P.O. BOX 2697
WOBURN,  MA  01888 -2697
Applicant Contact ROBERT R MURFITT
Correspondent
THERMEDICS, INC.
470 WILDWOOD ST.
P.O. BOX 2697
WOBURN,  MA  01888 -2697
Correspondent Contact ROBERT R MURFITT
Regulation Number876.5630
Classification Product Code
FKO  
Date Received12/11/1985
Decision Date 01/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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