FDA 510(k)

SITE MACROBORE PHACO NEEDLE

K-Number: K883099 · 1988-09-15

ApplicantSite Microsurgical Systems, Inc.

Decision Date1988-09-15

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

SITE MACROBORE 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 1988-09-15 under 510(k) number K883099. 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 MACROBORE PHACO NEEDLE?

SITE MACROBORE PHACO NEEDLE is a medical device that received FDA 510(k) clearance on 1988-09-15. The listed applicant is Site Microsurgical Systems, Inc.. The 510(k) number is K883099.

When did SITE MACROBORE PHACO NEEDLE receive FDA 510(k) clearance?

SITE MACROBORE PHACO NEEDLE received FDA 510(k) clearance on 1988-09-15, under 510(k) number K883099.

Who is the listed applicant for SITE MACROBORE 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 MACROBORE PHACO NEEDLE?

The FDA product code for SITE MACROBORE PHACO NEEDLE 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.