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FDA 510(k)

SCLERAL SHELL

K-Number: K970320 · 1997-07-07

ApplicantXavier A. Guerra, Ocularist, Inc.
Decision Date1997-07-07
Product CodeHQT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SCLERAL SHELL is the device name listed in this FDA 510(k) record. The listed applicant is Xavier A. Guerra, Ocularist, Inc.. It received FDA 510(k) clearance on 1997-07-07 under 510(k) number K970320. The device is classified under product code HQT. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCLERAL SHELL?

SCLERAL SHELL is a medical device that received FDA 510(k) clearance on 1997-07-07. The listed applicant is Xavier A. Guerra, Ocularist, Inc.. The 510(k) number is K970320.

When did SCLERAL SHELL receive FDA 510(k) clearance?

SCLERAL SHELL received FDA 510(k) clearance on 1997-07-07, under 510(k) number K970320.

Who is the listed applicant for SCLERAL SHELL?

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

What is the FDA product code for SCLERAL SHELL?

The FDA product code for SCLERAL SHELL is HQT.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Xavier A. Guerra, Ocularist, Inc. 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.

K970319OCULAR CONFORMER

Related Devices (Code: HQT)

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.

K970327SCLERAL SHELLSouthwest Artificial Eyes, Inc.K904961ARTIFICIAL SCLERAL SHELLMidwest Eye Laboratories, Inc.K855105SIMMONS SHELLMira, 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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