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510(k) K851188

PACKETS FOR PREP. OF DIALYSATES & INFUSATES - by Organon Teknika Corp. — Product Code FKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1985
Date Received
February 28, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Sorbent Regenerated
Device Class
Class II
Regulation Number
876.5600
Review Panel
GU
Submission Type

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  • K983762 — NUCLISENS CMV PP67 (September 15, 1999)
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  • K043574 — ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 (June 3, 2005)
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  • K954623 — REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNE (August 28, 1996)
  • K882428 — REDY 2000 (October 25, 1988)
  • K874137 — MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR (April 8, 1988)
  • K870270 — MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART. (February 25, 1987)