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FDA 510(k)

ICONNECTION 3D

K-Number: K012779 · 2001-11-02

ApplicantHinnovation, Inc.
Decision Date2001-11-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ICONNECTION 3D is the device name listed in this FDA 510(k) record. The listed applicant is Hinnovation, Inc.. It received FDA 510(k) clearance on 2001-11-02 under 510(k) number K012779. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICONNECTION 3D?

ICONNECTION 3D is a medical device that received FDA 510(k) clearance on 2001-11-02. The listed applicant is Hinnovation, Inc.. The 510(k) number is K012779.

When did ICONNECTION 3D receive FDA 510(k) clearance?

ICONNECTION 3D received FDA 510(k) clearance on 2001-11-02, under 510(k) number K012779.

Who is the listed applicant for ICONNECTION 3D?

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

What is the FDA product code for ICONNECTION 3D?

The FDA product code for ICONNECTION 3D is LLZ.

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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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