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FDA 510(k)

SURGICAL CUTTING BURS

K-Number: K943540 · 1994-11-30

ApplicantStryker Corp.
Decision Date1994-11-30
Product CodeDZJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SURGICAL CUTTING BURS is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 1994-11-30 under 510(k) number K943540. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL CUTTING BURS?

SURGICAL CUTTING BURS is a medical device that received FDA 510(k) clearance on 1994-11-30. The listed applicant is Stryker Corp.. The 510(k) number is K943540.

When did SURGICAL CUTTING BURS receive FDA 510(k) clearance?

SURGICAL CUTTING BURS received FDA 510(k) clearance on 1994-11-30, under 510(k) number K943540.

Who is the listed applicant for SURGICAL CUTTING BURS?

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

What is the FDA product code for SURGICAL CUTTING BURS?

The FDA product code for SURGICAL CUTTING BURS is DZJ.

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 Stryker Corp. 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.

View all 119 devices →

Related Devices (Code: DZJ)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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