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FDA 510(k)

LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)

K-Number: K121721 · 2012-10-15

Decision Date2012-10-15
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Medical Optics, Inc.. It received FDA 510(k) clearance on 2012-10-15 under 510(k) number K121721. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)?

LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) is a medical device that received FDA 510(k) clearance on 2012-10-15. The listed applicant is Abbott Medical Optics, Inc.. The 510(k) number is K121721.

When did LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) receive FDA 510(k) clearance?

LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) received FDA 510(k) clearance on 2012-10-15, under 510(k) number K121721.

Who is the listed applicant for LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)?

The FDA 510(k) record lists Abbott Medical Optics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)?

The FDA product code for LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) is HQC.

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.

Other records listing Abbott Medical Optics, 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.

View all 9 devices →

Related Devices (Code: HQC)

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.

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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