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FDA 510(k)

CORNEAL LIGHT SHIELD

K-Number: K850270 · 1985-05-31

ApplicantMentor O & O, Inc.
Decision Date1985-05-31
Product CodeHRM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CORNEAL LIGHT SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Mentor O & O, Inc.. It received FDA 510(k) clearance on 1985-05-31 under 510(k) number K850270. The device is classified under product code HRM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORNEAL LIGHT SHIELD?

CORNEAL LIGHT SHIELD is a medical device that received FDA 510(k) clearance on 1985-05-31. The listed applicant is Mentor O & O, Inc.. The 510(k) number is K850270.

When did CORNEAL LIGHT SHIELD receive FDA 510(k) clearance?

CORNEAL LIGHT SHIELD received FDA 510(k) clearance on 1985-05-31, under 510(k) number K850270.

Who is the listed applicant for CORNEAL LIGHT SHIELD?

The FDA 510(k) record lists Mentor O & O, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORNEAL LIGHT SHIELD?

The FDA product code for CORNEAL LIGHT SHIELD is HRM.

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Other records listing Mentor O & O, 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.

K955245MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEMK934320MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATIONK912904MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEMK915340MENTOR HORIZON LOW VISION MAGNIFIERK910637MENTOR(R) SUR-E-TROL(R)K911160MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305

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Related Devices (Code: HRM)

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.

K932720HM-0970Hill-Med, Inc.K930439MARCO SURGISCOPE OPERATION MICROSCOPESMarco Ophthalmic, Inc.K920641ALCON OPERATING MICROSCOPESAlcon LaboratoriesK914956KEELER KONAN SPECULAR MICROSCOPE SP5500Keeler Instruments, Inc.K891584S 22 INSTRUMENT STANDCarl Zeiss, Inc.K891001MICROSCOPE KNOB COVER, STERILE, DISPOSABLEPrescott'S, 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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