FDA 510(k)

PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)

K-Number: K984259 · 1999-01-21

Decision Date1999-01-21

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) is the device name listed in this FDA 510(k) record. The listed applicant is Cl-Tinters. It received FDA 510(k) clearance on 1999-01-21 under 510(k) number K984259. 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 PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)?

PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) is a medical device that received FDA 510(k) clearance on 1999-01-21. The listed applicant is Cl-Tinters. The 510(k) number is K984259.

When did PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) receive FDA 510(k) clearance?

PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) received FDA 510(k) clearance on 1999-01-21, under 510(k) number K984259.

Who is the listed applicant for PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)?

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

What is the FDA product code for PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)?

The FDA product code for PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) is LPL.

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 Cl-Tinters as applicant

K010126PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)K982774SOFT (HYDROPHILIC) CONTACT LENSES

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.