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FDA 510(k)

VISIOPLAST ACRYLIC RESIN

K-Number: K042414 · 2004-12-29

ApplicantTecres
Decision Date2004-12-29
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VISIOPLAST ACRYLIC RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Tecres. It received FDA 510(k) clearance on 2004-12-29 under 510(k) number K042414. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISIOPLAST ACRYLIC RESIN?

VISIOPLAST ACRYLIC RESIN is a medical device that received FDA 510(k) clearance on 2004-12-29. The listed applicant is Tecres. The 510(k) number is K042414.

When did VISIOPLAST ACRYLIC RESIN receive FDA 510(k) clearance?

VISIOPLAST ACRYLIC RESIN received FDA 510(k) clearance on 2004-12-29, under 510(k) number K042414.

Who is the listed applicant for VISIOPLAST ACRYLIC RESIN?

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

What is the FDA product code for VISIOPLAST ACRYLIC RESIN?

The FDA product code for VISIOPLAST ACRYLIC RESIN is GXP.

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Related Devices (Code: GXP)

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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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