FDA 510(k)

PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE

K-Number: K912902 · 1991-12-17

ApplicantSite Microsurgical Systems, Inc.

Decision Date1991-12-17

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

PHACOEMULSIFICATION SYSTEM FOR 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 1991-12-17 under 510(k) number K912902. 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 PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE?

PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE is a medical device that received FDA 510(k) clearance on 1991-12-17. The listed applicant is Site Microsurgical Systems, Inc.. The 510(k) number is K912902.

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

PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE received FDA 510(k) clearance on 1991-12-17, under 510(k) number K912902.

Who is the listed applicant for PHACOEMULSIFICATION SYSTEM FOR 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 PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE?

The FDA product code for PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE 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.