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510(k) K890997

ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) by Atlantic Wholesale, Inc. — Product Code KEA

K890997 is an FDA 510(k) premarket notification submitted by Atlantic Wholesale, Inc. for the device "ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC)". The FDA issued a decision of Substantially Equivalent on March 28, 1989. The device falls under product code KEA (Resins, Ion-Exchange), a Class I device regulated under 21 CFR 862.2230.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1989
Date Received
February 27, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resins, Ion-Exchange
Device Class
Class I
Regulation Number
862.2230
Review Panel
TX
Submission Type

Other clearances for product code KEA

  • K844948 — SYVA SOLID PHASE COLUMNS (August 29, 1985)
  • K842028 — CM-TRISACRYL M DEAE-TRISACRYL M (June 7, 1984)
  • K833320 — AMBERLITE CG50 RESIN, 100-200 MESH (December 8, 1983)
  • K833319 — BIO-REX 70 RESIN 100-200 MESH PH6.2 (November 3, 1983)
  • K831027 — EXTRELUT QE EXTRACTION COLUMNS (May 16, 1983)
  • K830918 — I.E.C COLUMN (April 27, 1983)
  • K782066 — EXETRELUT (January 3, 1979)
  • K781728 — EXTUBE (December 20, 1978)

FDA data resources