Tomy Inc FDA Filings

FDA Registration(s)

Registration Number	8010342
FEI Number	3002853098
Name	Michael van der Woude
Owner & Operator	TOMY, INC.
Contact Address	Tenko Blg. 3-16-7 Midoricho Fuchu City JP-13 Tokyo 183-0006 JP
Official Correspondent	Kenji - Nagase 81-42-3631151-x
US Agent	Michael van der Woude Emergo Global Representation LLC 512 3279997 512 3279998 USAgent@ul.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	2500 Bee Cave Road Bldg 1, Suite 300 Austin, TX 78746 US
Establishment Type	Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K180718 TOMY, Inc.	ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES	2018-10-30
PMN K160615 TOMY, INC	ORTHODONTIC CERAMIC BRACKETS 1.1	2016-08-26
PMN K123092 TOMY, INC.	CERAMIN BRACKETS Z	2012-12-21
PMN K123094 TOMY, INC.	ORTHODONTIC CERAMIC BRACKETS	2012-12-13
PMN K942826 \| DYW Michael van der Woude [TOMY, INC.]	Orthodontic Metal Reinforced Plastic Bracket	2012-02-16
PMN K932825 \| EJF Michael van der Woude [TOMY, INC.]	Microarch Gold Bracket	2012-02-16
PMN K932025 \| EJF Michael van der Woude [TOMY, INC.]	Wire, Orthodontic & Bracket, Metal Orthodontic	2012-02-16
PMN K932025 \| EJF Michael van der Woude [TOMY, INC.]	Ion-implanted NEO SENTALLOY	2012-02-16
PMN K932025 \| DZC Michael van der Woude [TOMY, INC.]	Wire, Orthodontic & Bracket, Metal Orthodontic	2012-02-16
PMN K932025 \| DZC Michael van der Woude [TOMY, INC.]	Ion-implanted NEO SENTALLOY	2012-02-16
PMN K920784 \| DZB Michael van der Woude [TOMY, INC.]	Orthodontic Face Bow W/ Inner Wire	2012-02-16
PMN K852179 \| EJF Michael van der Woude [TOMY, INC.]	CERAMIC ORTHODONTIC APPLIANCE	2012-02-16
PMN K092030 \| DYW Michael van der Woude [TOMY, INC.]	ELATION MB Metal Reinforced Plastic Bracket	2012-02-16
PMN K090454 \| NJM Michael van der Woude [TOMY, INC.]	ALLURE MB Ceramic Brackets	2012-02-16
PMN K082974 \| NJM Michael van der Woude [TOMY, INC.]	MYSTIQUE MB Ceramic Brackets	2012-02-16
PMN K060837 \| NJM Michael van der Woude [TOMY, INC.]	IN-OVATION C	2012-02-16
PMN K052370 \| DYW Michael van der Woude [TOMY, INC.]	CP BRACKET SYSTEM	2012-02-16
PMN K042178 \| NJM Michael van der Woude [TOMY, INC.]	Orthodontic Ceramic Brackets	2012-02-16