FDA 510(k)

POLY-CARB

K-Number: K022030 · 2002-08-28

Decision Date2002-08-28

Product CodeEBG

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

POLY-CARB is the device name listed in this FDA 510(k) record. The listed applicant is Inovativ, LLC. It received FDA 510(k) clearance on 2002-08-28 under 510(k) number K022030. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLY-CARB?

POLY-CARB is a medical device that received FDA 510(k) clearance on 2002-08-28. The listed applicant is Inovativ, LLC. The 510(k) number is K022030.

When did POLY-CARB receive FDA 510(k) clearance?

POLY-CARB received FDA 510(k) clearance on 2002-08-28, under 510(k) number K022030.

Who is the listed applicant for POLY-CARB?

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

What is the FDA product code for POLY-CARB?

The FDA product code for POLY-CARB is EBG.

Other records listing Inovativ, LLC 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.

K024282ACRYLIC K022032ACETAL

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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.