FDA 510(k)

SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE

K-Number: K871485 · 1987-06-03

ApplicantSite Microsurgical Systems, Inc.

Decision Date1987-06-03

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE 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 1987-06-03 under 510(k) number K871485. 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 PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE?

SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE is a medical device that received FDA 510(k) clearance on 1987-06-03. The listed applicant is Site Microsurgical Systems, Inc.. The 510(k) number is K871485.

When did SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE receive FDA 510(k) clearance?

SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE received FDA 510(k) clearance on 1987-06-03, under 510(k) number K871485.

Who is the listed applicant for SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE?

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 PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE?

The FDA product code for SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE 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.