FDA 510(k)

HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM

K-Number: K960287 · 1996-11-05

Decision Date1996-11-05

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1996-11-05 under 510(k) number K960287. 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 HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM?

HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM is a medical device that received FDA 510(k) clearance on 1996-11-05. The listed applicant is Nidek, Inc.. The 510(k) number is K960287.

When did HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM receive FDA 510(k) clearance?

HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM received FDA 510(k) clearance on 1996-11-05, under 510(k) number K960287.

Who is the listed applicant for HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM?

The FDA 510(k) record lists Nidek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM?

The FDA product code for HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM 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.