Flying Tooling Engineering L T D

FDA Filings

This page includes the latest FDA filings for Flying Tooling Engineering 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 Number3011185837
FEI Number3011185837
NameSteve Han
Owner & OperatorFlying Tooling Engineering Limited
Contact Address3rd Floor, No. 21, Xi Nan Lang Road Jinxia Community, Changan Town
Dongguan CN-44 Guangdong 523852 CN
Official Correspondent
  • Wenming Wang
  • 86-769-81589348-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7245 Garden Grove Blvd Ste C
Garden Grove, CA 92841 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Steve Han [Flying Tooling Engineering Limited]
B&B Blubber2018-12-01
Steve Han [Flying Tooling Engineering Limited]
Mouthport Adapter2016-12-05
Steve Han [Flying Tooling Engineering Limited]
BigEasy Valve2016-08-10
Steve Han [Flying Tooling Engineering Limited]
BigEasy Mask2016-08-10
Steve Han [Flying Tooling Engineering Limited]
Parallel Nose Clip2015-06-01

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020071039776Yantian,China (Mainland) -> Los Angeles, CaliforniaWATER SEAL CPAP VALVEFDA LISTING NO D335820 510K K133210150 CARTONS 7 PLASTIC PALLETSNO WOOD PACKING MATERIAL IS USED IN THE SHIPMENT SHIPPED ON BOARD150 CTN
2020070939289Yantian,China (Mainland) -> Los Angeles, CaliforniaWATER SEAL CPAP VALVEFDA LISTING NO D335820 510K K133210150 CARTONS 7 PLASTIC PALLETSNO WOOD PACKING MATERIAL IS USED IN THE SHIPMENT SHIPPED ON BOARD150 CTN
202005142920Yantian,China (Mainland) -> Jacksonville, FloridaBIGEASY MASK AND VALVE KIT. FDA LISTING NO. : D271728 AND D271726; 510K: K142402.200 CTN
202002183065Yantian,China (Mainland) -> Jacksonville, FloridaBIGEASY MASK AND VALVE KIT. FDA LISTING NO. : D271728 AND D271726. 510K: K142402. BIGE ASY MASK ONLY. FDA LISTING NO.: D271728200 CTN
2019102412294Yantian,China (Mainland) -> Jacksonville, FloridaBIGEASY MASK AND VALVE KIT. FDA LISTING NO. : D271728 AND D271726. 510K: K142402.200 CTN
2019051522832Yantian,China (Mainland) -> Los Angeles, CaliforniaWATER SEAL CPAP VALVEFDA LISTING NO D335820 510K K133210NO WOOD PACKING MATERIAL IS USED IN THE SHIPMENTSHIPPED ON BOARD 29042019 .250 CTN
201903133699Shekou,China (Mainland) -> Jacksonville, FloridaBIGEASY MASK AND VALVE KIT. FDA LISTING NO. : D271728 AND D271726. 510K: K142402400 CTN
201901294519Shekou,China (Mainland) -> Jacksonville, FloridaBIGEASY MASK AND VALVE KIT. FDA LISTING NO. : D271728 AND D271726; 510K: K142402. BIGE ASY MASK ONLY. FDA LISTING NO.: D271728200 CTN

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