FDA 510(k)

AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION

K-Number: K003345 · 2001-03-26

Decision Date2001-03-26

Product CodeLPN

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Ciba Vision Corporation. It received FDA 510(k) clearance on 2001-03-26 under 510(k) number K003345. 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 AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION?

AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION is a medical device that received FDA 510(k) clearance on 2001-03-26. The listed applicant is Ciba Vision Corporation. The 510(k) number is K003345.

When did AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION receive FDA 510(k) clearance?

AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION received FDA 510(k) clearance on 2001-03-26, under 510(k) number K003345.

Who is the listed applicant for AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION?

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

What is the FDA product code for AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION?

The FDA product code for AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION is LPN.

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Other records listing Ciba Vision Corporation as applicant

K123994DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL K113168DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC K083216CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES K073459CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES K072777CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES K062262CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS

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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.