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510(k) K023011

OSMONICS SOLUTION DELIVERY SYSTEM by Osmonics Medical Systems — Product Code FIN

K023011 is an FDA 510(k) premarket notification submitted by Osmonics Medical Systems for the device "OSMONICS SOLUTION DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 26, 2003. The device falls under product code FIN (Tank, Holding, Dialysis), a Class II device regulated under 21 CFR 876.5820.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2003
Date Received
September 9, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tank, Holding, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances for product code FIN

  • K140984 — TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM (January 12, 2015)
  • K141213 — AMERIWATER OZONE DISINFECTION SYSTEM (December 10, 2014)
  • K112427 — BICARB MIXING AND DISTRIBUTION SYSTEM (January 26, 2012)
  • K093641 — TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM (December 8, 2010)
  • K060333 — DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM (September 8, 2006)
  • K051031 — AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS (January 6, 2006)
  • K031502 — USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM (August 27, 2004)
  • K033118 — BIPRO MODEL SDS-CB200 (June 28, 2004)
  • K030366 — BICARD MIXING SYSTEM (April 19, 2004)
  • K003560 — MAR COR SERVICES BICARB SYSTEM (June 8, 2001)

FDA data resources