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510(k) K063395

O&P BIVALVE CRANIAL MOLDING HELMET by Orthotic & Prosthetic Lab, Inc. — Product Code MVA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2006
Date Received
November 9, 2006
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 Orthotic & Prosthetic Lab, Inc.

  • K021221 — O&P CRANICAL MOLDING HELMET (July 1, 2002)

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