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FDA 510(k)

FORMCORE DC, MODEL 28-700100

K-Number: K061664 · 2006-09-08

ApplicantJ. Morita USA, Inc.
Decision Date2006-09-08
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FORMCORE DC, MODEL 28-700100 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 2006-09-08 under 510(k) number K061664. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORMCORE DC, MODEL 28-700100?

FORMCORE DC, MODEL 28-700100 is a medical device that received FDA 510(k) clearance on 2006-09-08. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K061664.

When did FORMCORE DC, MODEL 28-700100 receive FDA 510(k) clearance?

FORMCORE DC, MODEL 28-700100 received FDA 510(k) clearance on 2006-09-08, under 510(k) number K061664.

Who is the listed applicant for FORMCORE DC, MODEL 28-700100?

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 FORMCORE DC, MODEL 28-700100?

The FDA product code for FORMCORE DC, MODEL 28-700100 is EBF.

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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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