CRANIAL REMOLDING ORTHOSIS— 510(k) K111247

Name: FDA 510(k) clearance K111247
Creator: U.S. Food and Drug Administration
Published: 2011-08-15

Substantially Equivalent

Orthotic Care Services, Llp

FDA 510(k) clearance K111247 for CRANIAL REMOLDING ORTHOSIS, Substantially Equivalent on 2011-08-15. Applicant: Orthotic Care Services, Llp. Device class: 2.

Clearance details

Applicant: Orthotic Care Services, Llp
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2011-05-03
Decision date: 2011-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St.Paul, MN, US

Download summary PDF View on FDA.gov ↗

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