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FDA 510(k)

PATTERN RESIN

K-Number: K003817 · 2001-01-16

ApplicantGC America, Inc.
Decision Date2001-01-16
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PATTERN RESIN 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 2001-01-16 under 510(k) number K003817. 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 PATTERN RESIN?

PATTERN RESIN is a medical device that received FDA 510(k) clearance on 2001-01-16. The listed applicant is GC America, Inc.. The 510(k) number is K003817.

When did PATTERN RESIN receive FDA 510(k) clearance?

PATTERN RESIN received FDA 510(k) clearance on 2001-01-16, under 510(k) number K003817.

Who is the listed applicant for PATTERN RESIN?

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 PATTERN RESIN?

The FDA product code for PATTERN RESIN is EBG.

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Related Devices (Code: EBG)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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