FDA 510(k)

GDLS-200

K-Number: K082434 · 2008-11-14

Decision Date2008-11-14

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

GDLS-200 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 2008-11-14 under 510(k) number K082434. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GDLS-200?

GDLS-200 is a medical device that received FDA 510(k) clearance on 2008-11-14. The listed applicant is GC America, Inc.. The 510(k) number is K082434.

When did GDLS-200 receive FDA 510(k) clearance?

GDLS-200 received FDA 510(k) clearance on 2008-11-14, under 510(k) number K082434.

Who is the listed applicant for GDLS-200?

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 GDLS-200?

The FDA product code for GDLS-200 is EBF.

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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Related Devices (Code: EBF)

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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.