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FDA 510(k)

OCULAR CONFORMER

K-Number: K970319 · 1997-07-07

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

Device Summary

OCULAR CONFORMER 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 K970319. The device is classified under product code HQN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCULAR CONFORMER?

OCULAR CONFORMER 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 K970319.

When did OCULAR CONFORMER receive FDA 510(k) clearance?

OCULAR CONFORMER received FDA 510(k) clearance on 1997-07-07, under 510(k) number K970319.

Who is the listed applicant for OCULAR CONFORMER?

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 OCULAR CONFORMER?

The FDA product code for OCULAR CONFORMER is HQN.

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.

K970320SCLERAL SHELL

Related Devices (Code: HQN)

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.

K972034MEDPOR OCULAR CONFORMERPorex Surgical, Inc.K970318OCULAR CONFORMERSouthwest Artificial Eyes, Inc.K945110KOLBERG OPHTHALMIC CONFORMERKolberg Ocular Products, Inc.K921221STERILE/SINGLE USE SYMBLEPHARON RINGStorz Instrument Co.K921229STERILE/SINGLE USE OPHTHALMIC CONFORMERSStorz Instrument Co.K772168MOLDEYERobert B. Scott Ocularists of Florida, 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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