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FDA 510(k)

GC AADVA ZR DISK

K-Number: K082740 · 2008-11-26

ApplicantGC America, Inc.
Decision Date2008-11-26
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GC AADVA ZR DISK is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 2008-11-26 under 510(k) number K082740. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GC AADVA ZR DISK?

GC AADVA ZR DISK is a medical device that received FDA 510(k) clearance on 2008-11-26. The listed applicant is GC America, Inc.. The 510(k) number is K082740.

When did GC AADVA ZR DISK receive FDA 510(k) clearance?

GC AADVA ZR DISK received FDA 510(k) clearance on 2008-11-26, under 510(k) number K082740.

Who is the listed applicant for GC AADVA ZR DISK?

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

What is the FDA product code for GC AADVA ZR DISK?

The FDA product code for GC AADVA ZR DISK is EIH.

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Related Devices (Code: EIH)

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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