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510(k) K840268

IRRIGATION SYSTEM by Coloplast A/S — Product Code EXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1984
Date Received
January 23, 1984
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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  • K871791 — BLOXOM IRRIGATOR (May 20, 1987)
  • K832299 — VISI-FLOW IRRIGATOR (August 26, 1983)
  • K823274 — UNI-TIP COLOSTOMY IRRIGATION CONE (December 7, 1982)
  • 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)