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510(k) K850756

AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS by Travenol Laboratories, S.A. — Product Code FKR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1985
Date Received
February 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Proportioning
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Travenol Laboratories, S.A.

  • K874181 — BAXTER BEDSIDE SYSTEM (February 22, 1988)
  • K873894 — CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE (November 5, 1987)
  • K873873 — RESUBMITTED MICRON TRANSFUSION FILTER (October 22, 1987)
  • K873984 — AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) (October 20, 1987)
  • K872364 — HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 (October 13, 1987)
  • K872652 — UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM (September 30, 1987)
  • K870801 — FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD (September 4, 1987)
  • K871908 — IV ADMINISTRATION SET (July 27, 1987)
  • K871471 — CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 (June 12, 1987)
  • K865029 — CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER (April 17, 1987)

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  • K060296 — NXSTAGE DIALYSATE PREPARATION MODULE (March 31, 2006)
  • K043436 — NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 (March 17, 2005)
  • K850435 — SARTORIUS AQUASART SM 40035 - DIALYSATE SYS (June 4, 1985)
  • K810605 — CHEMATIC BICARBONATE DIALYSATE SYSTEM (June 16, 1981)
  • K810127 — GAMBRO BICARBONATE MODULE, BCM-10 (February 25, 1981)
  • K802465 — BICARB-O-MATE HEMODIALYSIS SOD. BICARB. (November 12, 1980)
  • K800772 — MOD. DM-357 BICARBONATE RETROFIT KIT (May 14, 1980)