Opitek I N T

FDA Filings

This page includes the latest FDA filings for Opitek I N T. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010089520
FEI Number3010089520
NameDAN ALLEN
Owner & OperatorOpitek International
Contact AddressGoengehusvej 252
Vedbaek DK-84 Region Hovedstaden 2950 DK
Official Correspondent
  • Peter Christensen
  • 45-39-6616-44
US Agent
Importing Logistics Registration
ImporterDan Allen Surgical LLC - DBA D.A. Surgical
Address12373 Klinsman Rd.; Building C Suites 1-9
Newbury, OH 44065 UNITED STATES
Email Addressinfo@da-surgical.com
Phone1 440 2899788
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address12373 KINSMAN RD., BUILDING C SUITES 1-9
Newbury, OH 44065 US
Establishment TypeExport Device to the United States But Perform No Other Operation on Device

FDA Filings

Device
Company
DeviceDate
DAN ALLEN [Opitek International]
Velcro pads for 2006-602018-08-06
DAN ALLEN [Opitek International]
String Set, abdominal lift2018-08-06
DAN ALLEN [Opitek International]
Lift String, with velcro lock2018-08-06
DAN ALLEN [Opitek International]
Lift String, wide upholstered2018-08-06
DAN ALLEN [Opitek International]
Lift String, upholstered2018-08-06
DAN ALLEN [Opitek International]
Electrical Leg- & Armlift2018-08-06
DAN ALLEN [Opitek International]
Pedistirrup2018-08-06
DAN ALLEN [Opitek International]
Single use pad for Hip Fix, small2018-08-06
DAN ALLEN [Opitek International]
Single use pad for Hip Fix, large2018-08-06
DAN ALLEN [Opitek International]
Hip Fix mk.12018-08-06
DAN ALLEN [Opitek International]
Hip Fix 2015 series2018-08-06
DAN ALLEN [Opitek International]
Hip Fix 20002018-08-06
DAN ALLEN [Opitek International]
Hip Fix 1915 series2018-08-06

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