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FDA 510(k)

DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES

K-Number: K011456 · 2001-07-17

ApplicantSauflon Pharmaceuticals, Ltd.
Decision Date2001-07-17
Product CodeMRC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES is the device name listed in this FDA 510(k) record. The listed applicant is Sauflon Pharmaceuticals, Ltd.. It received FDA 510(k) clearance on 2001-07-17 under 510(k) number K011456. The device is classified under product code MRC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES?

DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES is a medical device that received FDA 510(k) clearance on 2001-07-17. The listed applicant is Sauflon Pharmaceuticals, Ltd.. The 510(k) number is K011456.

When did DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES receive FDA 510(k) clearance?

DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES received FDA 510(k) clearance on 2001-07-17, under 510(k) number K011456.

Who is the listed applicant for DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES?

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

What is the FDA product code for DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES?

The FDA product code for DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES is MRC.

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Other records listing Sauflon Pharmaceuticals, Ltd. as applicant

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.

K130342SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKERK130331SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKERK130734SAUFLON MULTIPURPOSE SOLUTIONK052832SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSESK052809SAUFLON FLAT COLOURED LENS CASEK033656SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE

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Related Devices (Code: MRC)

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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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