John Rafols

FDA Filings

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

FDA Registration(s)

• Registration Number: 3008494403
• FEI Number: 3008494403
• Name: John Rafols
• Owner & Operator: asap GmbH
• Contact Address: asap endoscopic products GmbH Stoeckmatten19; Umkirch DE-BW Baden-Wurttemberg 79224 DE
• Official Correspondent:
  • Horst Baholzer
  • 049-7665-947730-x
• US Agent:
  • John Rafols
  • 704 6608372
  • jrafols@pointemedical.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 102 Stone Point Court ; Mooresville, NC 28117 US
• Establishment Type:
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device
  • Foreign Private Label Distributor

FDA Filings

Device Company	Device	Date
PMN K121261 | HRX John Rafols [asap GmbH]	asap spine systems?	2013-06-20
PMN K121261 | HRX John Rafols [asap GmbH]	Multiscopes	2013-06-20
LXH John Rafols [asap GmbH]	THK020	2012-06-12
LXH John Rafols [asap GmbH]	THK019	2012-06-12
LXH John Rafols [asap GmbH]	LXH/E221945	2012-06-12
LXH John Rafols [asap GmbH]	Hook probe NITINOL	2012-06-12
LXH John Rafols [asap GmbH]	Dura-elevator NITINOL	2012-06-12
HTD John Rafols [asap GmbH]	Guide wire; Nitinol	2012-06-12
FZX John Rafols [asap GmbH]	THK026	2010-09-02
FZX John Rafols [asap GmbH]	Nitinol guide wire	2010-09-02
FZX John Rafols [asap GmbH]	FZX	2010-09-02
FWF John Rafols [asap GmbH]	Multifunction Video/Motionsystem	2009-11-13
FEM John Rafols [asap GmbH]	TV-Adapter	2009-11-13
PMN K032822 | EOB John Rafols [asap GmbH]	asap Sinuscope	2007-11-28
PMN K031974 | HIH John Rafols [asap GmbH]	asap gyn Laparoscope	2007-11-28
PMN K031974 | HIH John Rafols [asap GmbH]	asap Hysteroscope	2007-11-28
PMN K031974 | HET John Rafols [asap GmbH]	asap gyn Laparoscope	2007-11-28
PMN K031974 | HET John Rafols [asap GmbH]	asap Hysteroscope	2007-11-28
PMN K031972 | HRX John Rafols [asap GmbH]	asap Arthroscope	2007-11-28
PMN K031141 | FAJ John Rafols [asap GmbH]	asap Oesophagoscope	2007-11-28
PMN K031141 | FAJ John Rafols [asap GmbH]	asap Laryngoscope	2007-11-28
PMN K031141 | FAJ John Rafols [asap GmbH]	asap Laparoscope	2007-11-28
PMN K031141 | FAJ John Rafols [asap GmbH]	asap Cystoscope	2007-11-28
ERA John Rafols [asap GmbH]	Otoscope ENT	2007-11-28