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510(k) K140353

STARBAND AND STARLIGHT by Orthomerica Products, Inc. — Product Code MVA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2014
Date Received
February 12, 2014
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 Orthomerica Products, Inc.

  • K240466 — STARband 3D (March 15, 2024)
  • K223238 — STARband 3D (April 20, 2023)
  • K211376 — STARband (August 17, 2021)
  • K203098 — STARband, STARlight, St. Louis Band (April 27, 2021)
  • K180109 — STARband, STARlight, St. Louis Band (March 1, 2018)
  • K161138 — St. Louis Band (July 20, 2016)
  • K151979 — STARband, STARlight (September 18, 2015)
  • K151147 — STARband, STARlight (July 1, 2015)
  • K142141 — STARBAND, STARLIGHT (April 23, 2015)
  • K141842 — STARBAND, STARLIGHT (October 6, 2014)

Other clearances for product code MVA

  • K241957 — Talee, Talee PostOp (August 30, 2024)
  • K230444 — Talee, Talee PostOp (June 22, 2023)
  • K223238 — STARband 3D (April 20, 2023)
  • K220681 — Talee, Talee PostOP (September 22, 2022)
  • 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)