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FDA 510(k)

ROYALE AE 9036 LSP INJECTOR

K-Number: K073010 · 2007-11-07

ApplicantAsico, LLC
Decision Date2007-11-07
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ROYALE AE 9036 LSP INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Asico, LLC. It received FDA 510(k) clearance on 2007-11-07 under 510(k) number K073010. 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 ROYALE AE 9036 LSP INJECTOR?

ROYALE AE 9036 LSP INJECTOR is a medical device that received FDA 510(k) clearance on 2007-11-07. The listed applicant is Asico, LLC. The 510(k) number is K073010.

When did ROYALE AE 9036 LSP INJECTOR receive FDA 510(k) clearance?

ROYALE AE 9036 LSP INJECTOR received FDA 510(k) clearance on 2007-11-07, under 510(k) number K073010.

Who is the listed applicant for ROYALE AE 9036 LSP INJECTOR?

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

What is the FDA product code for ROYALE AE 9036 LSP INJECTOR?

The FDA product code for ROYALE AE 9036 LSP INJECTOR is MSS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Asico, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K103495ASICO SOFTIP INJECTOR SYSTEM

Related Devices (Code: MSS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261174RxSight® Insertion DeviceRxsight, Inc.K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AGK242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, IncorporatedK231106Accuject Refra Injector AR2900Medicel AGK231838RxSight® Insertion Device (63002)Rxsight, Inc.K231466RxSight Insertion DeviceRxsight, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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