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510(k) K911349

E-Z-EM ENTEROCLYSIS CATHETER SET by E-Z-Em, Inc. — Product Code EZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1992
Date Received
March 27, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

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Other clearances for product code EZK

  • K903816 — URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR (October 31, 1990)
  • K770408 — KARAYA GUM POWDER, OSTOMY (March 15, 1977)