FDA 510(k)

FROG

K-Number: K072831 · 2008-12-12

Decision Date2008-12-12

Product CodeFPD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

FROG is the device name listed in this FDA 510(k) record. The listed applicant is Newby-Coombs, LLC. It received FDA 510(k) clearance on 2008-12-12 under 510(k) number K072831. The device is classified under product code FPD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FROG?

FROG is a medical device that received FDA 510(k) clearance on 2008-12-12. The listed applicant is Newby-Coombs, LLC. The 510(k) number is K072831.

When did FROG receive FDA 510(k) clearance?

FROG received FDA 510(k) clearance on 2008-12-12, under 510(k) number K072831.

Who is the listed applicant for FROG?

The FDA 510(k) record lists Newby-Coombs, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FROG?

The FDA product code for FROG is FPD.

Related Devices (Code: FPD)

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.