Medical Device Manufacturer · US , Mchenry , IL

Coburn Optical Ind., Inc.

14 submissions · 14 cleared · Since 1978
14
Total
14
Cleared
0
Denied

Coburn Optical Ind., Inc. — FDA 510(k) Submissions

Coburn Optical Ind., Inc. has submitted 14 FDA 510(k) premarket notifications since 1978, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Reading, Television, Closed-circuit, Instrument, Vitreous Aspiration And Cutting, Ac-powered, Instrument, Visual Field, Laser, Laser, Ophthalmic, Instrument, Vitreous Aspiration And Cutting, Battery-powered . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
MAGNILINK SYSTEM 101
K892347 · HJG System, Reading,... · Ophthalmic
May 1989 51d
MAGNILINK SYSTEM 201
K892348 · HJG System, Reading,... · Ophthalmic
May 1989 51d
MAGNILINK SYSTEM 209
K892349 · HJG System, Reading,... · Ophthalmic
May 1989 51d
MAGNILINK SYSTEM 402/5
K892350 · HJG System, Reading,... · Ophthalmic
May 1989 51d
MAGNILINK SYSTEM 602
K892351 · HJG System, Reading,... · Ophthalmic
May 1989 51d
IRRIGATION & ASPIRATION/VITRECTOMY DEVICE
K862188 · HQE Instrument, Vitreous... · Ophthalmic
Aug 1986 73d
COBURN I/A SYSTEM
K853457 · HQE Instrument, Vitreous... · Ophthalmic
Oct 1985 60d
DISP. MICROSURGICAL KNIVES
K821737 · GES Blade, Scalpel · General & Plastic Surgery
Jul 1982 18d
DI-CROWN
K812441 · HQG Lens, Spectacle,... · Ophthalmic
Oct 1981 41d
AUTOMATED PERIMETERS
K803159 · HPT Perimeter, Automatic,... · Ophthalmic
Feb 1981 58d
BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE
K801659 · HJO Biomicroscope, Slit-lamp,... · Ophthalmic
Sep 1980 50d
EYE-VAC
K801231 · HKP Instrument, Vitreous... · Ophthalmic
Jul 1980 55d
MEDITEC (RODENSTOCK) LASER PHOTOCOAGUL
K791659 · HQF Laser, Ophthalmic · Radiology
Oct 1979 50d
RETINOMETER
K781507 · HPJ Instrument, Visual Field,... · Ophthalmic
Nov 1978 75d
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