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FDA 510(k)

IOLAB POWER I.V. POLE

K-Number: K921135 · 1992-06-03

ApplicantSite Microsurgical Systems, Inc.
Decision Date1992-06-03
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IOLAB POWER I.V. POLE 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 1992-06-03 under 510(k) number K921135. 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 IOLAB POWER I.V. POLE?

IOLAB POWER I.V. POLE is a medical device that received FDA 510(k) clearance on 1992-06-03. The listed applicant is Site Microsurgical Systems, Inc.. The 510(k) number is K921135.

When did IOLAB POWER I.V. POLE receive FDA 510(k) clearance?

IOLAB POWER I.V. POLE received FDA 510(k) clearance on 1992-06-03, under 510(k) number K921135.

Who is the listed applicant for IOLAB POWER I.V. POLE?

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 IOLAB POWER I.V. POLE?

The FDA product code for IOLAB POWER I.V. POLE is HQC.

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Other records listing Site Microsurgical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K925828MODIFIED SITE TXR SYSTEMSK925921MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTEK931866SITE'S CD II PHACOEMULSIFICATION HANDPIECEK920582180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.K912902PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USEK912739SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE

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Related Devices (Code: HQC)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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