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Found 2 results

510(k) Data Aggregation

K Number

Device Name

STAURENGHI WIDE FIELD SCANNING LASER LENS

Manufacturer

OCULAR INSTRUMENTS, INC.

Date Cleared

2002-03-04

(74 days)

Product Code

HJK

Regulation Number

886.1385

Why did this record match?

Applicant Name (Manufacturer) :

OCULAR INSTRUMENTS, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The Staurenghi Wide Field Scanning laser lens is indicated for use whenever a wide field scanning laser ophthalmoscope is indicated.

Device Description

Not Found

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K Number

Device Name

DISPOSABLE VITRECTOMY LENS

Manufacturer

OCULAR INSTRUMENTS, INC.

Date Cleared

2001-08-24

(50 days)

Product Code

HJK

Regulation Number

886.1385

Why did this record match?

Applicant Name (Manufacturer) :

OCULAR INSTRUMENTS, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Allow visualization of the ocular fundus, vitreous, and retinal structures during vitrectomy surgery.

Device Description

Disposable Vitrectomy Lens

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