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510(k) K801065

NIKKISO PARALLEL FLOW DIALYZERS by Int'L Marketing & Sales Corp. — Product Code FTG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1980
Date Received
May 6, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Illuminator, Remote
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances for product code FTG

  • K760815 — FITTING/DIALYZER (November 19, 1976)