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FDA 510(k)

RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM

K-Number: K931468 · 1994-07-12

ApplicantLifecore Biomedical, Inc.
Decision Date1994-07-12
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lifecore Biomedical, Inc.. It received FDA 510(k) clearance on 1994-07-12 under 510(k) number K931468. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM?

RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM is a medical device that received FDA 510(k) clearance on 1994-07-12. The listed applicant is Lifecore Biomedical, Inc.. The 510(k) number is K931468.

When did RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM receive FDA 510(k) clearance?

RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM received FDA 510(k) clearance on 1994-07-12, under 510(k) number K931468.

Who is the listed applicant for RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM?

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

What is the FDA product code for RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM?

The FDA product code for RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM is DZE.

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Other records listing Lifecore Biomedical, Inc. as applicant

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Related Devices (Code: DZE)

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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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