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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, for peritoneal dialysis, disposable
510(k) Number K912208
Device Name FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE
Applicant
FRESENIUS USA, INC.
4090 PIKE LN.
CONCORD,  CA  94520
Applicant Contact TOM FOLDEN
Correspondent
FRESENIUS USA, INC.
4090 PIKE LN.
CONCORD,  CA  94520
Correspondent Contact TOM FOLDEN
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received05/20/1991
Decision Date 07/24/1991
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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