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510(k) K781792

PRESSURIZER, EXETER CEMENT by Howmedica Corp. — Product Code KIZ

K781792 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "PRESSURIZER, EXETER CEMENT". The FDA issued a decision of Substantially Equivalent on February 8, 1979. The device falls under product code KIZ (Dish, Tissue Culture), a Class I device regulated under 21 CFR 864.2240. Howmedica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1979
Date Received
October 25, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dish, Tissue Culture
Device Class
Class I
Regulation Number
864.2240
Review Panel
PA
Submission Type

Other clearances by Howmedica Corp.

  • K984251 — XIA SPINE SYSTEM (February 24, 1999)
  • K984202 — HOWMEDICA HUMERAL INTERCALARY SYSTEM (February 5, 1999)
  • K984305 — ZETA MULTIZONE LOCKING NAIL SYSTEM (February 1, 1999)
  • K983885 — BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES (January 29, 1999)
  • K983528 — MICRO DYNAMIC MESH (December 23, 1998)
  • K983404 — TYPE 3 FEMORAL COMPONENTS (December 22, 1998)
  • K980925 — DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION (December 11, 1998)
  • K980632 — DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION (December 11, 1998)

Other clearances for product code KIZ

  • K890542 — MULTIWELL CULTURE PLATE INSERTS (February 14, 1989)
  • K873891 — TISSUE CULTURE DISHES (November 25, 1987)
  • K871483 — TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES (April 29, 1987)
  • K854724 — CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE (December 13, 1985)
  • K853634 — CORNING CELL WELLS-MULTIPLE WELL PLATES (September 16, 1985)
  • K821687 — REMOVAWELL TISSUE CULTURE PLATE W/LID (June 24, 1982)
  • K790958 — 120 WELL HISTO-PLATE (June 28, 1979)

FDA data resources