FDA 510(k)

CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES

K-Number: K943490 · 1994-08-11

Decision Date1994-08-11

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES is the device name listed in this FDA 510(k) record. The listed applicant is Continental Soft Lens, Inc.. It received FDA 510(k) clearance on 1994-08-11 under 510(k) number K943490. 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 CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES?

CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES is a medical device that received FDA 510(k) clearance on 1994-08-11. The listed applicant is Continental Soft Lens, Inc.. The 510(k) number is K943490.

When did CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES receive FDA 510(k) clearance?

CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES received FDA 510(k) clearance on 1994-08-11, under 510(k) number K943490.

Who is the listed applicant for CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES?

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

What is the FDA product code for CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES?

The FDA product code for CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES is LPL.

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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.