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510(k) K090341

MICHIGAN CRANIAL RESHAPING ORTHOSIS by Danmar Products, Inc. — Product Code MVA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2010
Date Received
February 10, 2009
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.

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  • K003630 — DANMAR PRODUCTS MICHIGAN CRANIAL HELMET (May 29, 2001)

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