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FDA 510(k)

FUSION PUTTY TYPE

K-Number: K043493 · 2005-03-04

ApplicantGC America, Inc.
Decision Date2005-03-04
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FUSION PUTTY TYPE 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 2005-03-04 under 510(k) number K043493. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUSION PUTTY TYPE?

FUSION PUTTY TYPE is a medical device that received FDA 510(k) clearance on 2005-03-04. The listed applicant is GC America, Inc.. The 510(k) number is K043493.

When did FUSION PUTTY TYPE receive FDA 510(k) clearance?

FUSION PUTTY TYPE received FDA 510(k) clearance on 2005-03-04, under 510(k) number K043493.

Who is the listed applicant for FUSION PUTTY TYPE?

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 FUSION PUTTY TYPE?

The FDA product code for FUSION PUTTY TYPE is ELW.

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Other records listing GC America, Inc. as applicant

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Related Devices (Code: ELW)

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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