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510(k) K180243

Infinity-Lock Button System by Xiros, Ltd. — Product Code HTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2018
Date Received
January 29, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Washer, Bolt Nut
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Xiros, Ltd.

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  • K220906 — SECURE-LOCK (July 22, 2022)
  • K211563 — Pitch-Patchs (August 13, 2021)
  • K191053 — Xtreme-Loop (July 17, 2019)
  • K171680 — Infinity-Lock 3, Infinity-Lock 5 (June 30, 2017)
  • K151601 — SECURE-LOOP (September 9, 2015)
  • K002172 — POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) (August 28, 2001)
  • K010051 — POLY-TAPES WITH THE FASTLOK FIXATION DEVICE (July 13, 2001)

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