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510(k) K111609

BOSTON BAND by Boston Brace Intl., Inc. — Product Code MVA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2011
Date Received
June 9, 2011
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 Boston Brace Intl., Inc.

  • K072862 — BOSTON-BAND CRANIAL REMODLING ORTHOSIS (January 22, 2008)
  • K063098 — STATIC CRANIOPLASTY ORTHOSIS (April 11, 2007)

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