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FDA 510(k)

EXCEL BOND DC, MODEL 28-200100

K-Number: K060882 · 2006-09-01

ApplicantJ. Morita USA, Inc.
Decision Date2006-09-01
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EXCEL BOND DC, MODEL 28-200100 is the device name listed in this FDA 510(k) record. The listed applicant is J. Morita USA, Inc.. It received FDA 510(k) clearance on 2006-09-01 under 510(k) number K060882. 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 EXCEL BOND DC, MODEL 28-200100?

EXCEL BOND DC, MODEL 28-200100 is a medical device that received FDA 510(k) clearance on 2006-09-01. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K060882.

When did EXCEL BOND DC, MODEL 28-200100 receive FDA 510(k) clearance?

EXCEL BOND DC, MODEL 28-200100 received FDA 510(k) clearance on 2006-09-01, under 510(k) number K060882.

Who is the listed applicant for EXCEL BOND DC, MODEL 28-200100?

The FDA 510(k) record lists J. Morita USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXCEL BOND DC, MODEL 28-200100?

The FDA product code for EXCEL BOND DC, MODEL 28-200100 is KLE.

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Related Devices (Code: KLE)

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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