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510(k) K761340

OSTOMY KARAYA GUM POWDER by Howmedica Corp. — Product Code EZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1977
Date Received
December 28, 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

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  • K983528 — MICRO DYNAMIC MESH (December 23, 1998)
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  • K980925 — DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980632 — DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION (December 11, 1998)
  • K980626 — DURATION II ACETABULAR COMPONENTS-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)
  • K770230 — KARAYA GUM POWDER (February 28, 1977)
  • K761319 — KARAYA GUM PRODUCTS - PROCESS CHANGE (February 15, 1977)