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FDA 510(k)

LIMA 28MM CERAMIC HEAD, MODIFICATION

K-Number: K912985 · 1991-12-24

ApplicantTurnkey Intergration USA, Inc.
Decision Date1991-12-24
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LIMA 28MM CERAMIC HEAD, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Turnkey Intergration USA, Inc.. It received FDA 510(k) clearance on 1991-12-24 under 510(k) number K912985. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIMA 28MM CERAMIC HEAD, MODIFICATION?

LIMA 28MM CERAMIC HEAD, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-12-24. The listed applicant is Turnkey Intergration USA, Inc.. The 510(k) number is K912985.

When did LIMA 28MM CERAMIC HEAD, MODIFICATION receive FDA 510(k) clearance?

LIMA 28MM CERAMIC HEAD, MODIFICATION received FDA 510(k) clearance on 1991-12-24, under 510(k) number K912985.

Who is the listed applicant for LIMA 28MM CERAMIC HEAD, MODIFICATION?

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

What is the FDA product code for LIMA 28MM CERAMIC HEAD, MODIFICATION?

The FDA product code for LIMA 28MM CERAMIC HEAD, MODIFICATION is LZO.

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Other records listing Turnkey Intergration USA, Inc. as applicant

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Related Devices (Code: LZO)

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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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