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FDA 510(k)

WHITE CORE

K-Number: K964931 · 1997-02-10

ApplicantBisco, Inc.
Decision Date1997-02-10
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

WHITE CORE is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 1997-02-10 under 510(k) number K964931. 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 WHITE CORE?

WHITE CORE is a medical device that received FDA 510(k) clearance on 1997-02-10. The listed applicant is Bisco, Inc.. The 510(k) number is K964931.

When did WHITE CORE receive FDA 510(k) clearance?

WHITE CORE received FDA 510(k) clearance on 1997-02-10, under 510(k) number K964931.

Who is the listed applicant for WHITE CORE?

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

What is the FDA product code for WHITE CORE?

The FDA product code for WHITE CORE is EBF.

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Other records listing Bisco, Inc. as applicant

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Related Devices (Code: 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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