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FDA 510(k)

PROFESSIONAL DISINFECTION SYSTEM (PDS)

K-Number: K863346 · 1987-02-27

ApplicantCiba Vision Care
Decision Date1987-02-27
Product CodeLPN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PROFESSIONAL DISINFECTION SYSTEM (PDS) is the device name listed in this FDA 510(k) record. The listed applicant is Ciba Vision Care. It received FDA 510(k) clearance on 1987-02-27 under 510(k) number K863346. 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 PROFESSIONAL DISINFECTION SYSTEM (PDS)?

PROFESSIONAL DISINFECTION SYSTEM (PDS) is a medical device that received FDA 510(k) clearance on 1987-02-27. The listed applicant is Ciba Vision Care. The 510(k) number is K863346.

When did PROFESSIONAL DISINFECTION SYSTEM (PDS) receive FDA 510(k) clearance?

PROFESSIONAL DISINFECTION SYSTEM (PDS) received FDA 510(k) clearance on 1987-02-27, under 510(k) number K863346.

Who is the listed applicant for PROFESSIONAL DISINFECTION SYSTEM (PDS)?

The FDA 510(k) record lists Ciba Vision Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROFESSIONAL DISINFECTION SYSTEM (PDS)?

The FDA product code for PROFESSIONAL DISINFECTION SYSTEM (PDS) is LPN.

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 Ciba Vision Care 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.

K853445IN A WINK LUBRICATING & REWETTING DROPS

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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