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510(k) K823274

UNI-TIP COLOSTOMY IRRIGATION CONE by Howmedica Corp. — Product Code EXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1982
Date Received
November 3, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Irrigator, Ostomy
Device Class
Class II
Regulation Number
876.5895
Review Panel
GU
Submission Type

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Other clearances for product code EXD

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  • K904586 — PALEX IRRIGATION SET (December 28, 1990)
  • K871791 — BLOXOM IRRIGATOR (May 20, 1987)
  • K840268 — IRRIGATION SYSTEM (April 5, 1984)
  • K832299 — VISI-FLOW IRRIGATOR (August 26, 1983)
  • K811160 — SUR-FIT IRRIGATION SLEEVE (June 2, 1981)
  • K790749 — COLOSTOMY ENEMA DEVICE (May 16, 1979)
  • K790750 — COLOSTOMY DEVICE W/ PRESSURE LID (May 14, 1979)
  • K770251 — SUPER X ADJUSTRETTE (February 28, 1977)