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FDA 510(k)

DWYER EYE SYSTEMS ASPIRATION UNIT

K-Number: K913261 · 1992-01-30

ApplicantSpectracare, Inc.
Decision Date1992-01-30
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DWYER EYE SYSTEMS ASPIRATION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Spectracare, Inc.. It received FDA 510(k) clearance on 1992-01-30 under 510(k) number K913261. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DWYER EYE SYSTEMS ASPIRATION UNIT?

DWYER EYE SYSTEMS ASPIRATION UNIT is a medical device that received FDA 510(k) clearance on 1992-01-30. The listed applicant is Spectracare, Inc.. The 510(k) number is K913261.

When did DWYER EYE SYSTEMS ASPIRATION UNIT receive FDA 510(k) clearance?

DWYER EYE SYSTEMS ASPIRATION UNIT received FDA 510(k) clearance on 1992-01-30, under 510(k) number K913261.

Who is the listed applicant for DWYER EYE SYSTEMS ASPIRATION UNIT?

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

What is the FDA product code for DWYER EYE SYSTEMS ASPIRATION UNIT?

The FDA product code for DWYER EYE SYSTEMS ASPIRATION UNIT is HQE.

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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.

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