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510(k) K003560

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

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)

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  • 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)