FDA 510(k)

KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10

K-Number: K000127 · 2000-04-12

Decision Date2000-04-12

Product CodeMML

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 is the device name listed in this FDA 510(k) record. The listed applicant is Heinz Kurz GmbH Medizintechnik. It received FDA 510(k) clearance on 2000-04-12 under 510(k) number K000127. The device is classified under product code MML. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10?

KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 is a medical device that received FDA 510(k) clearance on 2000-04-12. The listed applicant is Heinz Kurz GmbH Medizintechnik. The 510(k) number is K000127.

When did KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 receive FDA 510(k) clearance?

KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 received FDA 510(k) clearance on 2000-04-12, under 510(k) number K000127.

Who is the listed applicant for KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10?

The FDA 510(k) record lists Heinz Kurz GmbH Medizintechnik as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10?

The FDA product code for KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 is MML.

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Other records listing Heinz Kurz GmbH Medizintechnik as applicant

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Related Devices (Code: MML)

K170591Altomed Malhotra Platinum SegmentsAltomed Limited K021750LID CHAIN EYELID WEIGHTSJedmed Instrument Co.K011740CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)Meddev Corp.K011115KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010Heinz Kurz GmbH Medizintechnik K003646SUTUREGROOVE WEIGHT SIZING SETIop, Inc.K001123KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111Heinz Kurz GmbH Medizintechnik

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.