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510(k) K861646

BIO-CARB D16000, D16001, AND D17000 by Societe D' Analyses Bio-Pharmaceutiques,Inc. — Product Code FJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1986
Date Received
April 30, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Disposable
Device Class
Class II
Regulation Number
876.5830
Review Panel
GU
Submission Type

Other clearances for product code FJH

  • K920697 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP (September 21, 1992)
  • K852764 — IDECAP DIALYZER (September 20, 1985)
  • K822395 — CF 1211 CAPILLARY FLOW DIALYZER CODE (August 12, 1982)