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510(k) K040110

EASY LOOP, MODEL EZL-01 by Tools For Surgery, LLC — Product Code EZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2004
Date Received
January 20, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Colostomy
Device Class
Class II
Regulation Number
876.4270
Review Panel
GU
Submission Type

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  • K220218 — Siren SGT (May 18, 2022)
  • K040109 — HEMORRHAGE OCCLUDER PIN (March 25, 2004)

Other clearances for product code EZP

  • K052229 — COLOPLAST OSTOMY ROD, MODEL 12814 (October 13, 2006)