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510(k) K020448

STATIC CRANIOPLASTY ORTHOSIS by Eastern Cranial Affiliates — Product Code MVA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2002
Date Received
February 11, 2002
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 Eastern Cranial Affiliates

  • K180568 — KidCap (October 16, 2018)

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)