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FDA 510(k)

CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)

K-Number: K070694 · 2007-09-10

ApplicantMike Miner
Decision Date2007-09-10
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS) is the device name listed in this FDA 510(k) record. The listed applicant is Mike Miner. It received FDA 510(k) clearance on 2007-09-10 under 510(k) number K070694. 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 CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)?

CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS) is a medical device that received FDA 510(k) clearance on 2007-09-10. The listed applicant is Mike Miner. The 510(k) number is K070694.

When did CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS) receive FDA 510(k) clearance?

CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS) received FDA 510(k) clearance on 2007-09-10, under 510(k) number K070694.

Who is the listed applicant for CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)?

The FDA 510(k) record lists Mike Miner as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)?

The FDA product code for CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS) is MVA.

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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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