FDA 510(k)

SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE

K-Number: K904151 · 1990-12-05

ApplicantSite Microsurgical Systems, Inc.

Decision Date1990-12-05

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE 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 1990-12-05 under 510(k) number K904151. 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 19 GAUGE ULTRASONIC I/A PHACO NEEDLE?

SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE is a medical device that received FDA 510(k) clearance on 1990-12-05. The listed applicant is Site Microsurgical Systems, Inc.. The 510(k) number is K904151.

When did SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE receive FDA 510(k) clearance?

SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE received FDA 510(k) clearance on 1990-12-05, under 510(k) number K904151.

Who is the listed applicant for SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE?

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 19 GAUGE ULTRASONIC I/A PHACO NEEDLE?

The FDA product code for SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE is HQC.

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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.