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510(k) K042385

DOC BAND-POSTOP by Cranial Technologies, Inc. — Product Code MVA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2004
Date Received
September 1, 2004
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 Cranial Technologies, Inc.

  • K244056 — DOC Band 3D (March 17, 2025)
  • K014012 — DOC BAND (January 28, 2002)
  • DEN980001 — DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND (May 29, 1998)

Other clearances for product code MVA

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  • 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)