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510(k) K083785

VITALA CONTINENCE CONTROL DEVICE by Convatec — Product Code EZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2010
Date Received
December 19, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pouch, Colostomy
Device Class
Class I
Regulation Number
876.5900
Review Panel
GU
Submission Type

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Other clearances for product code EZQ

  • K111365 — VITALA CONTINENCE CONTROL DEVICE (August 19, 2011)
  • K102536 — VITALA CONTINENCE CONTROL DEVICE (December 1, 2010)
  • K922401 — 4 SURE TM COLOSTOMY POUCH (June 10, 1992)
  • K880327 — MARLEN ULTRA ILEOSTOMY POUCH-5000 (February 19, 1988)
  • K863830 — CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM (October 16, 1986)