FDA 510(k)

ESSTECH SV(POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS

K-Number: K942187 · 1994-07-28

Decision Date1994-07-28

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

ESSTECH SV(POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Szabocsik and Assoc.. It received FDA 510(k) clearance on 1994-07-28 under 510(k) number K942187. 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 ESSTECH SV(POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS?

ESSTECH SV(POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS is a medical device that received FDA 510(k) clearance on 1994-07-28. The listed applicant is Szabocsik and Assoc.. The 510(k) number is K942187.

When did ESSTECH SV(POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS receive FDA 510(k) clearance?

ESSTECH SV(POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS received FDA 510(k) clearance on 1994-07-28, under 510(k) number K942187.

Who is the listed applicant for ESSTECH SV(POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS?

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

What is the FDA product code for ESSTECH SV(POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS?

The FDA product code for ESSTECH SV(POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS is LPL.

Related Clinical Trials

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Other records listing Szabocsik and Assoc. as applicant

K974485SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION K951180ESSTECH SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS K942186ESSTECH PS ASPHERIC

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.