FDA 510(k)

SITE PHACO PLUS INFUSION SLEEVE

K-Number: K892852 · 1989-06-08

ApplicantSite Microsurgical Systems, Inc.

Decision Date1989-06-08

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

SITE PHACO PLUS INFUSION SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Site Microsurgical Systems, Inc.. It received FDA 510(k) clearance on 1989-06-08 under 510(k) number K892852. 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 SITE PHACO PLUS INFUSION SLEEVE?

SITE PHACO PLUS INFUSION SLEEVE is a medical device that received FDA 510(k) clearance on 1989-06-08. The listed applicant is Site Microsurgical Systems, Inc.. The 510(k) number is K892852.

When did SITE PHACO PLUS INFUSION SLEEVE receive FDA 510(k) clearance?

SITE PHACO PLUS INFUSION SLEEVE received FDA 510(k) clearance on 1989-06-08, under 510(k) number K892852.

Who is the listed applicant for SITE PHACO PLUS INFUSION SLEEVE?

The FDA 510(k) record lists Site Microsurgical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SITE PHACO PLUS INFUSION SLEEVE?

The FDA product code for SITE PHACO PLUS INFUSION SLEEVE is HQC.

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Other records listing Site Microsurgical Systems, Inc. as applicant

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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.