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510(k) K203134

Hanger Cranial Band 3D by Symbion Logistics, LLC — Product Code MVA

K203134 is an FDA 510(k) premarket notification submitted by Symbion Logistics, LLC for the device "Hanger Cranial Band 3D". The FDA issued a decision of Substantially Equivalent on July 1, 2022. The device falls under product code MVA (Orthosis, Cranial), a Class II device regulated under 21 CFR 882.5970.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2022
Date Received
October 19, 2020
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 for product code MVA

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

FDA data resources