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510(k) K803100

STOMAHESIVE PASTE PROTECTIVE SKIN BARR by E. R. Squibb & Sons, Inc. — Product Code EZR

K803100 is an FDA 510(k) premarket notification submitted by E. R. Squibb & Sons, Inc. for the device "STOMAHESIVE PASTE PROTECTIVE SKIN BARR". The FDA issued a decision of Substantially Equivalent on January 8, 1981. The device falls under product code EZR (Cement, Stomal Appliance, Ostomy), a Class I device regulated under 21 CFR 876.5900. E. R. Squibb & Sons, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1981
Date Received
December 9, 1980
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 E. R. Squibb & Sons, Inc.

  • K821494 — RIA STAT 16 (June 3, 1982)
  • K820616 — ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY (March 26, 1982)
  • K820340 — T3 UPTAKE-SQUIBB DIAGNOSTIC KIT (March 4, 1982)
  • K820341 — CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT (March 4, 1982)
  • K811240 — SUR-FIT LOOP OSTOMY O.R. SET (June 16, 1981)
  • K811239 — SUR-FIT DISPOSABLE CONVEX INSERT (June 9, 1981)
  • K811160 — SUR-FIT IRRIGATION SLEEVE (June 2, 1981)
  • K811163 — SUR-FIT DISPOSABLE FANGE CAP (May 21, 1981)
  • K810966 — DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT (April 21, 1981)
  • K810211 — T3 RIA KIT (February 10, 1981)

Other clearances for product code EZR

  • K844341 — UNITED SKIN BARRIER PASTE (January 18, 1985)
  • K791146 — COLO-TAPE (July 30, 1979)
  • K761340 — OSTOMY KARAYA GUM POWDER (March 7, 1977)
  • K770230 — KARAYA GUM POWDER (February 28, 1977)
  • K761319 — KARAYA GUM PRODUCTS - PROCESS CHANGE (February 15, 1977)

FDA data resources