FDA 510(k)

PHACO NEEDLES 1000-R & 1000-O NEEDLES

K-Number: K923630 · 1994-04-06

Decision Date1994-04-06

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

PHACO NEEDLES 1000-R & 1000-O NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is O.R. Specialties, Inc.. It received FDA 510(k) clearance on 1994-04-06 under 510(k) number K923630. 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 PHACO NEEDLES 1000-R & 1000-O NEEDLES?

PHACO NEEDLES 1000-R & 1000-O NEEDLES is a medical device that received FDA 510(k) clearance on 1994-04-06. The listed applicant is O.R. Specialties, Inc.. The 510(k) number is K923630.

When did PHACO NEEDLES 1000-R & 1000-O NEEDLES receive FDA 510(k) clearance?

PHACO NEEDLES 1000-R & 1000-O NEEDLES received FDA 510(k) clearance on 1994-04-06, under 510(k) number K923630.

Who is the listed applicant for PHACO NEEDLES 1000-R & 1000-O NEEDLES?

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

What is the FDA product code for PHACO NEEDLES 1000-R & 1000-O NEEDLES?

The FDA product code for PHACO NEEDLES 1000-R & 1000-O NEEDLES is HQC.

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Related Devices (Code: 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.