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510(k) K013452

DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS by Danmar Products, Inc. — Product Code MVA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2003
Date Received
October 18, 2001
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)
  • K003630 — DANMAR PRODUCTS MICHIGAN CRANIAL HELMET (May 29, 2001)

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