SAMIL ENTERPRISE COMPANY

FDA Device Registration & Listing · GYEONGBUK, KR · Registration 9615042

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9615042
FEI Number
1000185473
Entity Name
SAMIL ENTERPRISE COMPANY
City/State/Country
GYEONGBUK, KR
Establishment Address
542 HANTI-RO, DONGMYEONG-MYEON CHILGOK-GUN, GYEONGBUK 39855, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SAMIL ENTERPRISE CO. (Owner Number: 9043666)
Owner / Operator Contact Address
542 HANTI-RO DONGMYEONG-MYEON, CHILGOK-GUN, GYEONGBUK, KR-47 39855, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HQY Sunglasses (Non-Prescription Including Photosensitive) Ophthalmic Class 1 886.5850 2000-11-08
HQZ Frame, Spectacle Ophthalmic Class 1 886.5842 2000-11-08

Official Correspondent

FREDERICK SHIN

US Agent Details

Jennifer Ott Business: Rochester Optical Email: jennifer.ott@rochesteroptical.com Phone: (585) 7348395

Related Public Records

Same Entity

SAMIL ENTERPRISE CO.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K940726 Jay-Y Enterprises Co., Inc. NONE-GENERIC 1994-04-11
K934837 Simon Marketing, Inc. SUNGLASSES 1993-12-08
K852902 Yours Enterprise Co., Ltd. METALLIC SUNGLASSES 1985-08-12
K970895 Custom Optical Frames, Inc. CUSTOM OPTICAL SUNGLASS FRAMES 1997-05-06
K853921 Winsburn Company , Ltd. ALL KINDS OF SUNGLASSES 1985-10-15

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3013857947 FARFETCH ITALIA S.R.L. MILAN Milano, IT
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615042. Last updated year: 2026. Please use registration number 9615042 when referencing this establishment in official correspondence.
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