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510(k) K790749

COLOSTOMY ENEMA DEVICE by Vabar Corp. — Product Code EXD

K790749 is an FDA 510(k) premarket notification submitted by Vabar Corp. for the device "COLOSTOMY ENEMA DEVICE". The FDA issued a decision of Substantially Equivalent on May 16, 1979. The device falls under product code EXD (Irrigator, Ostomy), a Class II device regulated under 21 CFR 876.5895. Vabar Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 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.

  • K790750 — COLOSTOMY DEVICE W/ PRESSURE LID (May 14, 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)
  • K790750 — COLOSTOMY DEVICE W/ PRESSURE LID (May 14, 1979)
  • K760810 — TUBE, GASTRO-ENTEROSTOMY (February 28, 1977)

FDA data resources