Home / 510(k) Clearances / K003630

510(k) K003630

DANMAR PRODUCTS MICHIGAN CRANIAL HELMET by Danmar Products, Inc. — Product Code MVA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2001
Date Received
November 24, 2000
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 Danmar Products, Inc.

  • K090341 — MICHIGAN CRANIAL RESHAPING ORTHOSIS (January 6, 2010)
  • K013452 — DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS (October 31, 2003)

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)