Home / 510(k) Clearances / K790750

510(k) K790750

COLOSTOMY DEVICE W/ PRESSURE LID by Vabar Corp. — Product Code EXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1979
Date Received
April 17, 1979
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

Other clearances by Vabar Corp.

  • K790749 — COLOSTOMY ENEMA DEVICE (May 16, 1979)

Other clearances for product code EXD

  • K121833 — OSTOMY IRRIGATION SET (July 16, 2012)
  • K914692 — URINARY DIVERSION EVACUATING CATHETER (July 2, 1992)
  • 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)
  • K823274 — UNI-TIP COLOSTOMY IRRIGATION CONE (December 7, 1982)
  • K811160 — SUR-FIT IRRIGATION SLEEVE (June 2, 1981)
  • K790749 — COLOSTOMY ENEMA DEVICE (May 16, 1979)
  • K770251 — SUPER X ADJUSTRETTE (February 28, 1977)