FDA 510(k)

G-COAT

K-Number: K052462 · 2005-10-20

Decision Date2005-10-20

Product CodeEBD

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

G-COAT 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 2005-10-20 under 510(k) number K052462. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G-COAT?

G-COAT is a medical device that received FDA 510(k) clearance on 2005-10-20. The listed applicant is GC America, Inc.. The 510(k) number is K052462.

When did G-COAT receive FDA 510(k) clearance?

G-COAT received FDA 510(k) clearance on 2005-10-20, under 510(k) number K052462.

Who is the listed applicant for G-COAT?

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 G-COAT?

The FDA product code for G-COAT is EBD.

Other records listing GC America, Inc. as applicant

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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.