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510(k) K760815

FITTING/DIALYZER by Cobe Laboratories, Inc. — Product Code FTG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1976
Date Received
October 12, 1976
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

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  • K902759 — COBE CLOSED WOUND DRAINAGE KIT (July 18, 1990)

Other clearances for product code FTG

  • K801065 — NIKKISO PARALLEL FLOW DIALYZERS (August 7, 1980)