Home / 510(k) Clearances / K761319

510(k) K761319

KARAYA GUM PRODUCTS - PROCESS CHANGE by Howmedica Corp. — Product Code EZR

K761319 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "KARAYA GUM PRODUCTS - PROCESS CHANGE". The FDA issued a decision of Substantially Equivalent on February 15, 1977. The device falls under product code EZR (Cement, Stomal Appliance, Ostomy), a Class I device regulated under 21 CFR 876.5900. Howmedica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1977
Date Received
December 27, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Stomal Appliance, Ostomy
Device Class
Class I
Regulation Number
876.5900
Review Panel
GU
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 EZR

  • K844341 — UNITED SKIN BARRIER PASTE (January 18, 1985)
  • K803100 — STOMAHESIVE PASTE PROTECTIVE SKIN BARR (January 8, 1981)
  • K791146 — COLO-TAPE (July 30, 1979)
  • K761340 — OSTOMY KARAYA GUM POWDER (March 7, 1977)
  • K770230 — KARAYA GUM POWDER (February 28, 1977)

FDA data resources