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510(k) K770230

KARAYA GUM POWDER by Atlantic Surgical — Product Code EZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1977
Date Received
February 7, 1977
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 Atlantic Surgical

  • K820167 — LAMINATED KARAYA GUM WASHERS (February 18, 1982)
  • K772366 — BAG, DRAINAGEW/ADHESIVE; PROSTHESIS (January 26, 1978)

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)
  • K761319 — KARAYA GUM PRODUCTS - PROCESS CHANGE (February 15, 1977)