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FDA 510(k)

CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)

K-Number: K011740 · 2001-07-02

ApplicantMeddev Corp.
Decision Date2001-07-02
Product CodeMML
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) is the device name listed in this FDA 510(k) record. The listed applicant is Meddev Corp.. It received FDA 510(k) clearance on 2001-07-02 under 510(k) number K011740. 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 CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)?

CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) is a medical device that received FDA 510(k) clearance on 2001-07-02. The listed applicant is Meddev Corp.. The 510(k) number is K011740.

When did CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) receive FDA 510(k) clearance?

CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) received FDA 510(k) clearance on 2001-07-02, under 510(k) number K011740.

Who is the listed applicant for CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)?

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

What is the FDA product code for CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)?

The FDA product code for CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) is MML.

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.

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Other records listing Meddev 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.

K940974EYECLOSE EXTERNAL EYELID WEIGHTS

Related Devices (Code: MML)

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.

K170591Altomed Malhotra Platinum SegmentsAltomed LimitedK021750LID CHAIN EYELID WEIGHTSJedmed Instrument Co.K011115KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010Heinz Kurz GmbH MedizintechnikK003646SUTUREGROOVE WEIGHT SIZING SETIop, Inc.K001123KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111Heinz Kurz GmbH MedizintechnikK994289SUTUREGROOVEIop, Inc.

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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