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FDA 510(k)

SAUFLON MULTI LENS CARE SYSTEM

K-Number: K010559 · 2001-12-20

ApplicantSauflon Pharmaceuticals, Ltd.
Decision Date2001-12-20
Product CodeLPN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SAUFLON MULTI LENS CARE SYSTEM 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 2001-12-20 under 510(k) number K010559. The device is classified under product code LPN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAUFLON MULTI LENS CARE SYSTEM?

SAUFLON MULTI LENS CARE SYSTEM is a medical device that received FDA 510(k) clearance on 2001-12-20. The listed applicant is Sauflon Pharmaceuticals, Ltd.. The 510(k) number is K010559.

When did SAUFLON MULTI LENS CARE SYSTEM receive FDA 510(k) clearance?

SAUFLON MULTI LENS CARE SYSTEM received FDA 510(k) clearance on 2001-12-20, under 510(k) number K010559.

Who is the listed applicant for SAUFLON MULTI LENS CARE SYSTEM?

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 SAUFLON MULTI LENS CARE SYSTEM?

The FDA product code for SAUFLON MULTI LENS CARE SYSTEM is LPN.

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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: LPN)

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.

K253795MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd.K222541Bausch + Lomb Preservative Free Lubricating and Rewetting DropsBausch & Lomb, IncorporatedK221263Aqua Naina Plus Sterile Saline SolutionChemtex USA, Inc.K202932ABT12 multi-purpose solutionBausch & Lomb, IncorporatedK210051OTE MPS 045 Multi-purpose Lens Care SolutionOte North America, LLCK193441Aqua Naina Sterile Saline SolutionChemtex USA, Inc.

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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