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510(k) K230444

Talee, Talee PostOp by Invent Medical USA, LLC — Product Code MVA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2023
Date Received
February 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Cranial
Device Class
Class II
Regulation Number
882.5970
Review Panel
NE
Submission Type

Other clearances by Invent Medical USA, LLC

  • K241957 — Talee, Talee PostOp (August 30, 2024)
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  • K203134 — Hanger Cranial Band 3D (July 1, 2022)
  • K213587 — MyCRO Band (June 9, 2022)
  • K193383 — SnugKap (June 7, 2021)
  • K201426 — MyCRO Band (March 26, 2021)
  • K180568 — KidCap (October 16, 2018)
  • K141842 — STARBAND, STARLIGHT (October 6, 2014)
  • K140353 — STARBAND AND STARLIGHT (June 6, 2014)