FDA 510(k)

SITE PHACOEMULSIFICATION HANDPIECE

K-Number: K904183 · 1990-12-05

ApplicantSite Microsurgical Systems, Inc.

Decision Date1990-12-05

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

SITE PHACOEMULSIFICATION HANDPIECE 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 K904183. 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 HANDPIECE?

SITE PHACOEMULSIFICATION HANDPIECE 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 K904183.

When did SITE PHACOEMULSIFICATION HANDPIECE receive FDA 510(k) clearance?

SITE PHACOEMULSIFICATION HANDPIECE received FDA 510(k) clearance on 1990-12-05, under 510(k) number K904183.

Who is the listed applicant for SITE PHACOEMULSIFICATION HANDPIECE?

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 HANDPIECE?

The FDA product code for SITE PHACOEMULSIFICATION HANDPIECE is HQC.

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Other records listing Site Microsurgical Systems, Inc. as applicant

K925828MODIFIED SITE TXR SYSTEMS K925921MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE K931866SITE'S CD II PHACOEMULSIFICATION HANDPIECE K921135IOLAB POWER I.V. POLE K920582180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.K912902PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE

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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.