FDA 510(k)

COPC BAND

K-Number: K021594 · 2003-11-13

ApplicantCenter For Orthotic and Prosthetic Care,Llc

Decision Date2003-11-13

Product CodeMVA

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

COPC BAND is the device name listed in this FDA 510(k) record. The listed applicant is Center For Orthotic and Prosthetic Care,Llc. It received FDA 510(k) clearance on 2003-11-13 under 510(k) number K021594. 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 COPC BAND?

COPC BAND is a medical device that received FDA 510(k) clearance on 2003-11-13. The listed applicant is Center For Orthotic and Prosthetic Care,Llc. The 510(k) number is K021594.

When did COPC BAND receive FDA 510(k) clearance?

COPC BAND received FDA 510(k) clearance on 2003-11-13, under 510(k) number K021594.

Who is the listed applicant for COPC BAND?

The FDA 510(k) record lists Center For Orthotic and Prosthetic Care,Llc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COPC BAND?

The FDA product code for COPC BAND is MVA.

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, LLC K230444Talee, Talee PostOpInvent Medical USA, LLC K223238STARband 3DOrthomerica Products, Inc.K220681Talee, Talee PostOPInvent Medical USA, LLC K203134Hanger Cranial Band 3DSymbion Logistics, LLC K213587MyCRO BandOtto Bock Healthcare LP

Official Source

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