Contour Optik Inc

FDA Filings

This page includes the latest FDA filings for Contour Optik Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number

3007774542

FEI Number

3007774542

Name

CONTOUR OPTIK(JIANGXI) CO., LTD

Owner & Operator

CONTOUR OPTIK INC.

Contact Address

6 INDUSTRIAL FIFTH RD., TOU CHIAU INDUSTRIAL PARK
CHIAYI TW-NOTA 62155 TW

Official Correspondent

GEORGE W CHAO
886-5-2207633-x

US Agent

Kevin Chao
425 5919821
kevintchao@hotmail.com

Importing Logistics Registration

Importer	REM EYEWEAR
Address	10941 LA TUNA CANYON ROAD Sun Valley, CA 91352 UNITED STATES
Importer Type	Broker

Registration Status

Initial Importer

Registration Expiration

2020-04-25

Registration Address

YUJIANG INTERNATIONAL GLASSES INDUSTRY PARK YINGTAN CITY,JIANGXI PROVINCE,CHINA
YINGTAN Jiangxi, 335000 CN

Establishment Type

Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility

Registration Number	8020477
FEI Number	3002340647
Name	Kevin Chao
Owner & Operator	CONTOUR OPTIK INC.
Contact Address	6 INDUSTRIAL FIFTH RD., TOU CHIAU INDUSTRIAL PARK CHIAYI TW-NOTA 62155 TW
Official Correspondent	GEORGE W CHAO 886-5-2207633-x
US Agent	Kevin Chao 425 5919821 kevintchao@hotmail.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	12826 SE 41st Lane, Unit D102. Bellevue, WA 98006 US
Establishment Type	Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K131440 \| LZA Kevin Chao [CONTOUR OPTIK INC.]	Polymer patient glove	2020-04-11
PMN K131440 \| LZA CONTOUR OPTIK(JIANGXI) CO., LTD [CONTOUR OPTIK INC.]	Polymer patient glove	2020-04-11
PMN K102718 \| FLL Kevin Chao [CONTOUR OPTIK INC.]	Thermometer, electronic, clinical	2020-04-10
PMN K102718 \| FLL CONTOUR OPTIK(JIANGXI) CO., LTD [CONTOUR OPTIK INC.]	Thermometer, electronic, clinical	2020-04-10
KPY Kevin Chao [CONTOUR OPTIK INC.]	Shield, protective, personnel	2020-04-10
KPY CONTOUR OPTIK(JIANGXI) CO., LTD [CONTOUR OPTIK INC.]	Shield, protective, personnel	2020-04-10
LDE Kevin Chao [CONTOUR OPTIK INC.]	STETHOSCOPE, MANUAL, Disposable Stethoscopes	2020-04-08
LDE CONTOUR OPTIK(JIANGXI) CO., LTD [CONTOUR OPTIK INC.]	STETHOSCOPE, MANUAL, Disposable Stethoscopes	2020-04-08
MSH Kevin Chao [CONTOUR OPTIK INC.]	Respirator, surgical, N95 mask, K N95 mask	2020-03-31
MSH CONTOUR OPTIK(JIANGXI) CO., LTD [CONTOUR OPTIK INC.]	Respirator, surgical, N95 mask, K N95 mask	2020-03-31
HOY Kevin Chao [CONTOUR OPTIK INC.]	Shield, eye, ophthalmic, Vented goggles, Non-vented goggles	2020-03-31
HOY CONTOUR OPTIK(JIANGXI) CO., LTD [CONTOUR OPTIK INC.]	Shield, eye, ophthalmic, Vented goggles, Non-vented goggles	2020-03-31
OEA Kevin Chao [CONTOUR OPTIK INC.]	Non-surgical isolation gown, Coveralls Hoods, Lab coat	2020-03-29
OEA CONTOUR OPTIK(JIANGXI) CO., LTD [CONTOUR OPTIK INC.]	Non-surgical isolation gown, Coveralls Hoods, Lab coat	2020-03-29
KHA Kevin Chao [CONTOUR OPTIK INC.]	MASK, SCAVENGING, Face Mask	2020-03-29
KHA CONTOUR OPTIK(JIANGXI) CO., LTD [CONTOUR OPTIK INC.]	MASK, SCAVENGING, Face Mask	2020-03-29
KME Kevin Chao [CONTOUR OPTIK INC.]	Bedding, Disposable, Medical	2020-03-26
KME CONTOUR OPTIK(JIANGXI) CO., LTD [CONTOUR OPTIK INC.]	Bedding, Disposable, Medical	2020-03-26
IWO Kevin Chao [CONTOUR OPTIK INC.]	Apron, protective	2020-03-25
IWO CONTOUR OPTIK(JIANGXI) CO., LTD [CONTOUR OPTIK INC.]	Apron, protective	2020-03-25
LYU Kevin Chao [CONTOUR OPTIK INC.]	ACCESSORY, SURGICAL APPAREL, FACE MASK	2020-03-19
LYU CONTOUR OPTIK(JIANGXI) CO., LTD [CONTOUR OPTIK INC.]	ACCESSORY, SURGICAL APPAREL, FACE MASK	2020-03-19
NJH CONTOUR OPTIK(JIANGXI) CO., LTD [CONTOUR OPTIK INC.]	NON-CUSTOM (PRESCRIPTION)	2019-09-23
HJF Kevin Chao [CONTOUR OPTIK INC.]	NON-CUSTOM (PRESCRIPTION)	2010-10-22
HJF CONTOUR OPTIK(JIANGXI) CO., LTD [CONTOUR OPTIK INC.]	NON-CUSTOM (PRESCRIPTION)	2010-10-22
HQZ Kevin Chao [CONTOUR OPTIK INC.]	NON-CUSTOM (PRESCRIPTION)	2007-05-23
HQZ CONTOUR OPTIK(JIANGXI) CO., LTD [CONTOUR OPTIK INC.]	NON-CUSTOM (PRESCRIPTION)	2007-05-23
HQY Kevin Chao [CONTOUR OPTIK INC.]	NON-CUSTOM (PRESCRIPTION)	2007-05-23
HQY CONTOUR OPTIK(JIANGXI) CO., LTD [CONTOUR OPTIK INC.]	NON-CUSTOM (PRESCRIPTION)	2007-05-23
HQG Kevin Chao [CONTOUR OPTIK INC.]	NON-CUSTOM (PRESCRIPTION)	2007-05-23
HQG CONTOUR OPTIK(JIANGXI) CO., LTD [CONTOUR OPTIK INC.]	NON-CUSTOM (PRESCRIPTION)	2007-05-23
HOI Kevin Chao [CONTOUR OPTIK INC.]	NON-CUSTOM (PRESCRIPTION)	2007-05-23
HOI CONTOUR OPTIK(JIANGXI) CO., LTD [CONTOUR OPTIK INC.]	NON-CUSTOM (PRESCRIPTION)	2007-05-23

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Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092961990	Shanghai ,China (Mainland) -> Long Beach, California	PM2 5 CARBON FILTER MASK INSERT NON MEDICAL DISPOSABLE . . . . .	2225 CTN
2020092658400	Taipei,China (Taiwan) -> Los Angeles, California	READING GLASSES INVOICE NO BT20 09009 HS CODE 900490 . . . .	40 CTN
2020092548776	Shanghai ,China (Mainland) -> Long Beach, California	READING GLASSES	52 CTN
2020092528215	Yantian,China (Mainland) -> Los Angeles, California	CPE GOWN . . . . . .	840 CTN
2020092151983	Shanghai ,China (Mainland) -> Long Beach, California	READING GLASSES	33 CTN
2020091774533	Shanghai ,China (Mainland) -> Long Beach, California	PLASTIC OPTICAL FRAME	8 CTN
2020091496785	Shanghai ,China (Mainland) -> Long Beach, California	PART OF GLASSES GLASSES	42 CTN
2020091066989	Shanghai ,China (Mainland) -> Long Beach, California	READING GLASSES	8 CTN