O&P BIVALVE CRANIAL MOLDING HELMET— 510(k) K063395

Name: FDA 510(k) clearance K063395
Creator: U.S. Food and Drug Administration
Published: 2006-12-22

Substantially Equivalent

Orthotic & Prosthetic Lab, Inc.

FDA 510(k) clearance K063395 for O&P BIVALVE CRANIAL MOLDING HELMET, Substantially Equivalent on 2006-12-22. Applicant: Orthotic & Prosthetic Lab, Inc.. Device class: 2.

Clearance details

Applicant: Orthotic & Prosthetic Lab, Inc.
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2006-11-09
Decision date: 2006-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Webster Groves, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MVA

view all

K241957 — Talee, Talee PostOp2024-08-30
K230444 — Talee, Talee PostOp2023-06-22
K223238 — STARband 3D2023-04-20
K220681 — Talee, Talee PostOP2022-09-22
K203134 — Hanger Cranial Band 3D2022-07-01

More clearances from Orthotic & Prosthetic Lab, Inc.

view all

K021221 — O&P CRANICAL MOLDING HELMET2002-07-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.