FDA 510(k)

FUJI BOND LC

K-Number: K953166 · 1995-09-27

Decision Date1995-09-27

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

FUJI BOND LC 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 1995-09-27 under 510(k) number K953166. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJI BOND LC?

FUJI BOND LC is a medical device that received FDA 510(k) clearance on 1995-09-27. The listed applicant is GC America, Inc.. The 510(k) number is K953166.

When did FUJI BOND LC receive FDA 510(k) clearance?

FUJI BOND LC received FDA 510(k) clearance on 1995-09-27, under 510(k) number K953166.

Who is the listed applicant for FUJI BOND LC?

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 FUJI BOND LC?

The FDA product code for FUJI BOND LC is KLE.

Other records listing GC America, Inc. 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.

K262202Cerasmart Forte K253317Cytrans™ Elashield K261246SRGC-06 K254109G-CEM UNIVERSAL K251124G-Bond Universal K250953EQUIA LC ONE

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Related Devices (Code: KLE)

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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.