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510(k) K802075

HOLLOW FIBER DIALYZER HOLDER by Renal Devices, Inc. — Product Code FKI

K802075 is an FDA 510(k) premarket notification submitted by Renal Devices, Inc. for the device "HOLLOW FIBER DIALYZER HOLDER". The FDA issued a decision of Substantially Equivalent on September 16, 1980. The device falls under product code FKI (Set, Dialyzer Holder), a Class II device regulated under 21 CFR 876.5820. Renal Devices, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1980
Date Received
August 27, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Dialyzer Holder
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Renal Devices, Inc.

  • K810612 — HEMOPHRON (April 29, 1981)
  • K801559 — HOLLO FIBER DIALYZER (October 31, 1980)
  • K790696 — RDI-1 HOLLOW FIBER DIALYZER (June 20, 1979)

Other clearances for product code FKI

  • K843504 — AMER. BENTLEY HEMOFILTER HOLDER HFH-1 (October 18, 1984)
  • K811292 — PARALLEL PLATE DIALYZER HOLDER (June 2, 1981)

FDA data resources