FDA 510(k)

SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE

K-Number: K912739 · 1991-08-28

ApplicantSite Microsurgical Systems, Inc.

Decision Date1991-08-28

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH 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 1991-08-28 under 510(k) number K912739. 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 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE?

SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE is a medical device that received FDA 510(k) clearance on 1991-08-28. The listed applicant is Site Microsurgical Systems, Inc.. The 510(k) number is K912739.

When did SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE receive FDA 510(k) clearance?

SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE received FDA 510(k) clearance on 1991-08-28, under 510(k) number K912739.

Who is the listed applicant for SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH 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 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE?

The FDA product code for SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH 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.