Mercedes Bayani FDA Filings

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
9616784	3007035078	Mercedes Bayani	1	N	2020-04-25	Bioness 25103 Rye Canyon Loop Valencia CA US 91355

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
85810	1997768273	K122784	NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT	GZI	2012-12-27
85810	1498599910	K103343	L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)	GZI	2011-04-29
85810	2033914153	K080219	MODIFICATION TO:NESS L300	GZI	2008-02-28
85810	2006279205	K053468	NESS L300	GZI	2006-07-07
85810	2013965098	K031900	HANDMASTER	GZI	2003-08-08

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GZI	5	2012-12-27