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FDA 510(k)

O&P BIVALVE CRANIAL MOLDING HELMET

K-Number: K063395 · 2006-12-22

ApplicantOrthotic & Prosthetic Lab, Inc.
Decision Date2006-12-22
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

O&P BIVALVE CRANIAL MOLDING HELMET is the device name listed in this FDA 510(k) record. The listed applicant is Orthotic & Prosthetic Lab, Inc.. It received FDA 510(k) clearance on 2006-12-22 under 510(k) number K063395. The device is classified under product code MVA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O&P BIVALVE CRANIAL MOLDING HELMET?

O&P BIVALVE CRANIAL MOLDING HELMET is a medical device that received FDA 510(k) clearance on 2006-12-22. The listed applicant is Orthotic & Prosthetic Lab, Inc.. The 510(k) number is K063395.

When did O&P BIVALVE CRANIAL MOLDING HELMET receive FDA 510(k) clearance?

O&P BIVALVE CRANIAL MOLDING HELMET received FDA 510(k) clearance on 2006-12-22, under 510(k) number K063395.

Who is the listed applicant for O&P BIVALVE CRANIAL MOLDING HELMET?

The FDA 510(k) record lists Orthotic & Prosthetic Lab, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for O&P BIVALVE CRANIAL MOLDING HELMET?

The FDA product code for O&P BIVALVE CRANIAL MOLDING HELMET is MVA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Orthotic & Prosthetic Lab, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K021221O&P CRANICAL MOLDING HELMET

Related Devices (Code: MVA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241957Talee, Talee PostOpInvent Medical USA, LLCK230444Talee, Talee PostOpInvent Medical USA, LLCK223238STARband 3DOrthomerica Products, Inc.K220681Talee, Talee PostOPInvent Medical USA, LLCK203134Hanger Cranial Band 3DSymbion Logistics, LLCK213587MyCRO BandOtto Bock Healthcare LP

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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