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510(k) DEN980001

DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND by Cranial Technologies, Inc. — Product Code MVA

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
May 29, 1998
Date Received
March 31, 1998
Clearance Type
Post-NSE
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)
  • K042385 — DOC BAND-POSTOP (December 17, 2004)
  • K014012 — DOC BAND (January 28, 2002)

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)