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FDA 510(k)

BLINK EXTERNAL EYELID WEIGHT

K-Number: K971245 · 1997-06-20

ApplicantIpax, Inc.
Decision Date1997-06-20
Product CodeMML
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BLINK EXTERNAL EYELID WEIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Ipax, Inc.. It received FDA 510(k) clearance on 1997-06-20 under 510(k) number K971245. 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 BLINK EXTERNAL EYELID WEIGHT?

BLINK EXTERNAL EYELID WEIGHT is a medical device that received FDA 510(k) clearance on 1997-06-20. The listed applicant is Ipax, Inc.. The 510(k) number is K971245.

When did BLINK EXTERNAL EYELID WEIGHT receive FDA 510(k) clearance?

BLINK EXTERNAL EYELID WEIGHT received FDA 510(k) clearance on 1997-06-20, under 510(k) number K971245.

Who is the listed applicant for BLINK EXTERNAL EYELID WEIGHT?

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

What is the FDA product code for BLINK EXTERNAL EYELID WEIGHT?

The FDA product code for BLINK EXTERNAL EYELID WEIGHT is MML.

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Other records listing Ipax, Inc. as applicant

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K200893ProntoPump Sterile Tube SetK971242BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)K915158SUREBREATH DOME, E-Z BREATHERK915118PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBEK914221KPE 220 TS, NONSTERILEK914172KPE 230 AM

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Related Devices (Code: MML)

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K170591Altomed Malhotra Platinum SegmentsAltomed LimitedK021750LID 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 MedizintechnikK003646SUTUREGROOVE 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.

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