TRUE FUNCTION LABORATORY INC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3007108578	3007108578	TRUE FUNCTION LABORATORY INC	1	N	2026-01-01	7851 University Ave Ste 102 La Mesa CA US 91942

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
156780	1198563764	K954530	THE SILENCER	LRK	1995-10-30
156780	1403573923	K190236	O2Vent Optima	LRK	2019-08-29
156780	1860070105	K180691	TrueDorsal Devices	LRK	2019-02-11
156780	1301198405	K171316	O2Vent W	LRK	2017-07-11
156780	1605934720	K170578	True Function Adjustable Herbst Appliances	LRK	2017-11-24
156780	1815284229	K161832	O2VENT T	LRK	2016-09-23
156780	1026562616	K083209	ACRYLIC HERBST SPLINT APPLIANCE	LRK	2009-01-27
156780	1663336766	K062951	TAP III ANTI-SNORING DEVICE	LRK	2006-12-12
156780	1586588940	K030440	OASYS-ORAL AIRWAY SYSTEM	LRK	2003-08-26
156780	1581939222

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LRK	9	2019-08-29

PMN#

TrueDorsal Devices
2019-02-11
True Function Laboratory, Inc.
True Function Adjustable Herbst Appliances
2017-11-24
True Function Laboratory, Inc.

GUDID#

TrueFunction Adjustable Herbst Appliance - Oral device used to treat obstructive sleep apnea
TRUE FUNCTION LABORATORY
2019-09-01
TrueDorsal Devices - Oral device used to treat obstructive sleep apnea
TRUE FUNCTION LABORATORY
2019-09-01