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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 K871154
Device Name DELFLEX SAFE LOCK CAPD PATIENT ASSIST DEVICE
Applicant
DELMED, INC.
P.O. DRAWER 190
FREEHOLD,  NJ  07728
Applicant Contact DOERSCHUK, PHD
Correspondent
DELMED, INC.
P.O. DRAWER 190
FREEHOLD,  NJ  07728
Correspondent Contact DOERSCHUK, PHD
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received03/24/1987
Decision Date 04/30/1987
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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