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FDA 510(k)

BOBES LENS SET

K-Number: K945443 · 1995-07-19

ApplicantBobes S.A.
Decision Date1995-07-19
Product CodeHPC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BOBES LENS SET is the device name listed in this FDA 510(k) record. The listed applicant is Bobes S.A.. It received FDA 510(k) clearance on 1995-07-19 under 510(k) number K945443. The device is classified under product code HPC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOBES LENS SET?

BOBES LENS SET is a medical device that received FDA 510(k) clearance on 1995-07-19. The listed applicant is Bobes S.A.. The 510(k) number is K945443.

When did BOBES LENS SET receive FDA 510(k) clearance?

BOBES LENS SET received FDA 510(k) clearance on 1995-07-19, under 510(k) number K945443.

Who is the listed applicant for BOBES LENS SET?

The FDA 510(k) record lists Bobes S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOBES LENS SET?

The FDA product code for BOBES LENS SET is HPC.

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 Bobes S.A. 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.

K945445BOBES SLIT LAMPK945446BOBES TONOMETER

Related Devices (Code: HPC)

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.

K951437OTI MODEL TLS-60Oti Medical, LLCK930195OPHTHALMIC TRIAL LENSESOptimark Accessories and InstrumentsK934859CONTACT LENSESArno Intl., Inc.K930446MARCO TRIAL SETSMarco Ophthalmic, Inc.K924786BURTON TRIAL LENS SETR.H. Burton Co.K920571TRIAL LENS SETR.H. Burton Co.

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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