Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1932994

FEI Number

1000218142

Entity Name

STONY BROOK

City/State/Country

Shakopee, MN, US

Establishment Address

1933 Belmont Ave NW, Shakopee, MN 55379, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

STONY BROOK/SIL-OPHTHO LLC (Owner Number: 9010129)

Owner / Operator Contact Address

1933 Belmont Ave NW, Shakopee, MN 55379, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sil-ophtho

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQH	Eye, Artificial, Non-Custom	Ophthalmic	Class 1	886.3200	2009-01-29

Official Correspondent

MELANIE TESTER FLEMING

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STONY BROOK/SIL-OPHTHO LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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2935668	STEVEN R. YOUNG OCULARIST, INC.	OAKLAND, CA, US
3006342671	JUNE R.R. NICHOLS, OCULARIST LTD. d/b/a OCULARISTS Ltd	DES PLAINES, IL, US
3004475955	ISCON SURGICALS, LTD.	JODHPUR Rajasthan, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1932994. Last updated year: 2026. Please use registration number 1932994 when referencing this establishment in official correspondence.