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510(k) K193383

SnugKap by Headstart, Ltd. — Product Code MVA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2021
Date Received
December 5, 2019
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

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