Shahak Tec L T D

FDA Filings

This page includes the latest FDA filings for Shahak Tec L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010223399
• FEI Number: 3010223399
• Name: David Lennarz
• Owner & Operator: Shahak-Tec Ltd.
• Contact Address: 1, AvShalom Road POB 166; Zichron Yaakov IL-NOTA 3095101 IL
• US Agent:
  • David Lennarz
  • Registrar Corp
  • 757 2240177
  • 757 2240179
  • david.lennarz@registrarcorp.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 144 Research Drive ; Hampton, VA 23666 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
BYH David Lennarz [Shahak-Tec Ltd.]	Watertrap	2014-11-24
PMN K980324 | CCK David Lennarz [Shahak-Tec Ltd.]	Sure VentLine Set	2013-01-10
PMN K980324 | CCK David Lennarz [Shahak-Tec Ltd.]	FilterLine Set, Adult Pediatric	2013-01-10
PMN K093388 | CCK David Lennarz [Shahak-Tec Ltd.]	Smart CapnoLine Guardian	2013-01-10
PMN K093388 | CCK David Lennarz [Shahak-Tec Ltd.]	Smart CapnoLine Guardian LONG	2013-01-10
PMN K013845 | CCK David Lennarz [Shahak-Tec Ltd.]	Smart SureLine Plus O2	2013-01-10
PMN K011536 | CCK David Lennarz [Shahak-Tec Ltd.]	Smart CapnoLine Plus O2	2013-01-10
PMN K011536 | CCK David Lennarz [Shahak-Tec Ltd.]	Smart CapnoLine Plus O2 LONG	2013-01-10
PMN K011536 | CCK David Lennarz [Shahak-Tec Ltd.]	Smart CapnoLine Plus H O2	2013-01-10
PMN K011536 | CCK David Lennarz [Shahak-Tec Ltd.]	Smart CapnoLine O2 Pediatric	2013-01-10
PMN K010024 | CCK David Lennarz [Shahak-Tec Ltd.]	CAPNOLINE H O2 ADULT	2013-01-10
PMN K980327 | CCK David Lennarz [Shahak-Tec Ltd.]	VitaLine H Set, Adult Pediatric	2013-01-09
PMN K980327 | CCK David Lennarz [Shahak-Tec Ltd.]	Sure VentLine H Set	2013-01-09
PMN K980327 | CCK David Lennarz [Shahak-Tec Ltd.]	FilterLine Set, Infant/Neonate	2013-01-09
PMN K980327 | CCK David Lennarz [Shahak-Tec Ltd.]	FilterLine H Set, Adult/Pediatric	2013-01-09

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092980745	Haifa,Israel -> New York/Newark Area, Newark, New Jersey	1248 CARTONS OF PLASTIC PA RTS FOR EQUIPMENT FOR RESE ARCH LABS INV#200400779	1248 CTN
2020091177652	Haifa,Israel -> New York/Newark Area, Newark, New Jersey	472 CARTONS OF PLASTIC PAR TS FOR EQUIPMENT F OR RESEA RCH LABS INV#200400704	472 CTN
2020091179886	Rotterdam,Netherlands -> Boston, Massachusetts	1338 CARTONS OF PLASTIC PA RTS FOR EQUIPMENT FOR RESE ARCH LABS INV#200400665	1338 CTN
2020090548625	Haifa,Israel -> New York/Newark Area, Newark, New Jersey	1372 CARTONS OF PLASTIC PA RTS FOR EQUIPMENT FOR RESE ARCH LABS INV#200400693	1372 CTN
2020082164804	Rotterdam,Netherlands -> Boston, Massachusetts	1322 CARTONS OF PLASTIC PA RTS FOR EQUIPMENT FOR RESE ARCH LABS INV#200400574	1322 CTN
2020081451134	Rotterdam,Netherlands -> Boston, Massachusetts	1395 CARTONS OF PLASTIC PA RTS FOR EQUIPMENT FOR RESE ARCH LABS INV#200400562	1395 CTN
2020073168777	Rotterdam,Netherlands -> Boston, Massachusetts	1188 CARTONS OF PLASTIC PA RTS FOR EQUIPMENT FOR RESE ARCH LABS INV#200400489	1188 CTN
2020071863627	Rotterdam,Netherlands -> Boston, Massachusetts	1018 CARTONS OF PLASTIC PA RTS FOR EQUIPMENT FOR RESE ARCH LABS INV#200400448	1018 CTN