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FDA 510(k)

ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626

K-Number: K012435 · 2001-10-02

ApplicantBausch & Lomb, Inc.
Decision Date2001-10-02
Product CodeNGY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Inc.. It received FDA 510(k) clearance on 2001-10-02 under 510(k) number K012435. The device is classified under product code NGY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626?

ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 is a medical device that received FDA 510(k) clearance on 2001-10-02. The listed applicant is Bausch & Lomb, Inc.. The 510(k) number is K012435.

When did ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 receive FDA 510(k) clearance?

ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 received FDA 510(k) clearance on 2001-10-02, under 510(k) number K012435.

Who is the listed applicant for ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626?

The FDA 510(k) record lists Bausch & Lomb, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626?

The FDA product code for ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 is NGY.

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Other records listing Bausch & Lomb, Inc. 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.

K192005Bausch + Lomb PreVue Inserter for enVista PreloadedK173480Crystalsert Lens Delivery SystemK161012Easy-Load Lens Delivery SystemK131208BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,K122575BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VIK113852BAUSCH & LOMB IOL INJECTOR

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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.

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