FDA 510(k)

POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE)

K-Number: K980818 · 1998-03-30

Decision Date1998-03-30

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE) is the device name listed in this FDA 510(k) record. The listed applicant is Stephen A. Dunn, Inc.. It received FDA 510(k) clearance on 1998-03-30 under 510(k) number K980818. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE)?

POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE) is a medical device that received FDA 510(k) clearance on 1998-03-30. The listed applicant is Stephen A. Dunn, Inc.. The 510(k) number is K980818.

When did POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE) receive FDA 510(k) clearance?

POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE) received FDA 510(k) clearance on 1998-03-30, under 510(k) number K980818.

Who is the listed applicant for POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE)?

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

What is the FDA product code for POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE)?

The FDA product code for POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE) is LPL.

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Other records listing Stephen A. Dunn, Inc. as applicant

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Related Devices (Code: LPL)

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.