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510(k) K003560

MAR COR SERVICES BICARB SYSTEM by Mar Cor Services, Inc. — Product Code FIN

K003560 is an FDA 510(k) premarket notification submitted by Mar Cor Services, Inc. for the device "MAR COR SERVICES BICARB SYSTEM". The FDA issued a decision of Substantially Equivalent on June 8, 2001. The device falls under product code FIN (Tank, Holding, Dialysis), a Class II device regulated under 21 CFR 876.5820. Mar Cor Services, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2001
Date Received
November 17, 2000
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 by Mar Cor Services, Inc.

  • K003877 — MAR COR SERVICES SEMPER PURE RO MACHINE (June 22, 2001)
  • K945559 — MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS (May 28, 1996)

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)
  • K023011 — OSMONICS SOLUTION DELIVERY SYSTEM (June 26, 2003)

FDA data resources