CRANIAL HELMET— 510(k) K013458

Substantially Equivalent

Children'S Hospital

FDA 510(k) clearance K013458 for CRANIAL HELMET, Substantially Equivalent on 2001-10-29. Applicant: Children'S Hospital.

Clearance details

Applicant: Children'S Hospital
Product code: Code MVA
Advisory panel: Neurology
Date received: 2001-10-18
Decision date: 2001-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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