FDA 510(k)

STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION)

K-Number: K951824 · 1995-07-19

Decision Date1995-07-19

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION) is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1995-07-19 under 510(k) number K951824. 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 STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION)?

STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION) is a medical device that received FDA 510(k) clearance on 1995-07-19. The listed applicant is Nidek, Inc.. The 510(k) number is K951824.

When did STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION) receive FDA 510(k) clearance?

STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION) received FDA 510(k) clearance on 1995-07-19, under 510(k) number K951824.

Who is the listed applicant for STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION)?

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 STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION)?

The FDA product code for STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION) 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.