FDA 510(k)

GC GAM-100

K-Number: K073283 · 2008-02-20

Decision Date2008-02-20

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

GC GAM-100 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 2008-02-20 under 510(k) number K073283. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GC GAM-100?

GC GAM-100 is a medical device that received FDA 510(k) clearance on 2008-02-20. The listed applicant is GC America, Inc.. The 510(k) number is K073283.

When did GC GAM-100 receive FDA 510(k) clearance?

GC GAM-100 received FDA 510(k) clearance on 2008-02-20, under 510(k) number K073283.

Who is the listed applicant for GC GAM-100?

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 GAM-100?

The FDA product code for GC GAM-100 is EMA.

Other records listing GC America, 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.

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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.