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FDA 510(k)

RT600

K-Number: K103366 · 2011-04-04

ApplicantRestorative Therapies, Inc.
Decision Date2011-04-04
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RT600 is the device name listed in this FDA 510(k) record. The listed applicant is Restorative Therapies, Inc.. It received FDA 510(k) clearance on 2011-04-04 under 510(k) number K103366. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RT600?

RT600 is a medical device that received FDA 510(k) clearance on 2011-04-04. The listed applicant is Restorative Therapies, Inc.. The 510(k) number is K103366.

When did RT600 receive FDA 510(k) clearance?

RT600 received FDA 510(k) clearance on 2011-04-04, under 510(k) number K103366.

Who is the listed applicant for RT600?

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

What is the FDA product code for RT600?

The FDA product code for RT600 is GZI.

Other records listing Restorative Therapies, Inc. as applicant

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Related Devices (Code: GZI)

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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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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