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FDA 510(k)

BISBLOCK

K-Number: K033521 · 2004-01-16

ApplicantBisco, Inc.
Decision Date2004-01-16
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BISBLOCK is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2004-01-16 under 510(k) number K033521. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BISBLOCK?

BISBLOCK is a medical device that received FDA 510(k) clearance on 2004-01-16. The listed applicant is Bisco, Inc.. The 510(k) number is K033521.

When did BISBLOCK receive FDA 510(k) clearance?

BISBLOCK received FDA 510(k) clearance on 2004-01-16, under 510(k) number K033521.

Who is the listed applicant for BISBLOCK?

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 BISBLOCK?

The FDA product code for BISBLOCK is EJK.

Related Clinical Trials

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.

Other records listing Bisco, 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.

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Related Devices (Code: EJK)

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.

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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