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FDA 510(k)

DOC BAND-POSTOP

K-Number: K042385 · 2004-12-17

ApplicantCranial Technologies, Inc.
Decision Date2004-12-17
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DOC BAND-POSTOP is the device name listed in this FDA 510(k) record. The listed applicant is Cranial Technologies, Inc.. It received FDA 510(k) clearance on 2004-12-17 under 510(k) number K042385. 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 DOC BAND-POSTOP?

DOC BAND-POSTOP is a medical device that received FDA 510(k) clearance on 2004-12-17. The listed applicant is Cranial Technologies, Inc.. The 510(k) number is K042385.

When did DOC BAND-POSTOP receive FDA 510(k) clearance?

DOC BAND-POSTOP received FDA 510(k) clearance on 2004-12-17, under 510(k) number K042385.

Who is the listed applicant for DOC BAND-POSTOP?

The FDA 510(k) record lists Cranial Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOC BAND-POSTOP?

The FDA product code for DOC BAND-POSTOP is MVA.

Related Clinical Trials

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Other records listing Cranial Technologies, 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.

K244056DOC Band 3DK014012DOC BAND

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

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

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