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510(k) K881270

GAMBRO MULTIPURPOSE SYSTEM MPS-10 by Gambro, Inc. — Product Code FII

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1988
Date Received
March 24, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Sealed
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

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  • K892523 — GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY (May 11, 1989)
  • K890112 — ENGSTROM ELIZA + CO2 ANALYZER (March 15, 1989)

Other clearances for product code FII

  • K030470 — NXSTAGE SYSTEM ONE (July 7, 2003)
  • K872364 — HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 (October 13, 1987)
  • K862716 — HEMOFILTRATION SYSTEM 10 (September 9, 1986)
  • K822386 — COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA (October 6, 1982)