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510(k) K180568

KidCap by Eastern Cranial Affiliates, LLC — Product Code MVA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2018
Date Received
March 5, 2018
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 Eastern Cranial Affiliates, LLC

  • K020448 — STATIC CRANIOPLASTY ORTHOSIS (April 12, 2002)

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