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FDA 510(k)

HOYA IS INJECTOR SYSTEM

K-Number: K081346 · 2009-03-23

ApplicantHoya Surgical Optics, Inc.
Decision Date2009-03-23
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HOYA IS INJECTOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hoya Surgical Optics, Inc.. It received FDA 510(k) clearance on 2009-03-23 under 510(k) number K081346. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOYA IS INJECTOR SYSTEM?

HOYA IS INJECTOR SYSTEM is a medical device that received FDA 510(k) clearance on 2009-03-23. The listed applicant is Hoya Surgical Optics, Inc.. The 510(k) number is K081346.

When did HOYA IS INJECTOR SYSTEM receive FDA 510(k) clearance?

HOYA IS INJECTOR SYSTEM received FDA 510(k) clearance on 2009-03-23, under 510(k) number K081346.

Who is the listed applicant for HOYA IS INJECTOR SYSTEM?

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

What is the FDA product code for HOYA IS INJECTOR SYSTEM?

The FDA product code for HOYA IS INJECTOR SYSTEM is MSS.

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Related Devices (Code: MSS)

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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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