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FDA 510(k)

LINK ENDO MODEL REVISION CUP

K-Number: K943986 · 1995-07-05

ApplicantTurnkey Intergration USA, Inc.
Decision Date1995-07-05
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINK ENDO MODEL REVISION CUP 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 1995-07-05 under 510(k) number K943986. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINK ENDO MODEL REVISION CUP?

LINK ENDO MODEL REVISION CUP is a medical device that received FDA 510(k) clearance on 1995-07-05. The listed applicant is Turnkey Intergration USA, Inc.. The 510(k) number is K943986.

When did LINK ENDO MODEL REVISION CUP receive FDA 510(k) clearance?

LINK ENDO MODEL REVISION CUP received FDA 510(k) clearance on 1995-07-05, under 510(k) number K943986.

Who is the listed applicant for LINK ENDO MODEL REVISION CUP?

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 LINK ENDO MODEL REVISION CUP?

The FDA product code for LINK ENDO MODEL REVISION CUP is HRS.

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Other records listing Turnkey Intergration USA, Inc. as applicant

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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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