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510(k) K791146

COLO-TAPE by Suburban Ostomy Supply Co., Inc. — Product Code EZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1979
Date Received
June 18, 1979
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 for product code EZR

  • K844341 — UNITED SKIN BARRIER PASTE (January 18, 1985)
  • K803100 — STOMAHESIVE PASTE PROTECTIVE SKIN BARR (January 8, 1981)
  • K761340 — OSTOMY KARAYA GUM POWDER (March 7, 1977)
  • K770230 — KARAYA GUM POWDER (February 28, 1977)
  • K761319 — KARAYA GUM PRODUCTS - PROCESS CHANGE (February 15, 1977)