FDA.reportPublic FDA data

510(k) K801628

Device
Restraint, Protective
Applicant
THE OWENBY CO.
510(k) number
K801628
Product code
IQK
Decision
Substantially Equivalent (SESE)
Decision date
1980-08-07
Date received
1980-07-15
Regulation
890.3490
Classification name
Orthosis, Cervical
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IQK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K930730DORMIE NECK SUPPORT SYSTEMThe Western Diagnostics Co.1993-07-22
K926291SCHUL-TEC IMMOBILIZERMedical Emergency Support Equipment1993-03-30
K895477NOVA PILLOWNova Health Systems, Inc.1990-01-10
K896042MEDICAL DISPOSABLE BEDDINGKeystone Veterinary Supplies, Inc.1990-01-10
K882264BATTLE CREEK PILLOWBattle Creek Equipment Co.1988-08-09
K850465CERVICAL COLLARS & HEAD HALTERSAbco Dealers, Inc.1985-04-25
K832990STIFNICK IMMOBILIZING COLLARLaerdal California, Inc.1983-11-07
K832001HEAD-IMMOBILIZERInt'L Safety Corp.1983-07-12
K831582VARI-SUPPORT NECK POSTURE PILLOWBody Therapeutics, Inc.1983-06-15
K830348VINYL EXTRICATION COLLARDeip Enterprises, Inc.1983-03-09
K830350CERVICAL PILLOWDeip Enterprises, Inc.1983-03-09
K830351DISPOSABLE EXTRICATION COLLARDeip Enterprises, Inc.1983-03-09
K823667CERVICAL COLLARWarm & Form, Orthopedic Materials1982-12-30
K823247U-WAY QUICKOLLAREms Industries, Inc.1982-11-16
K823161CERVICAL COLLARWarm & Form, Orthopedic Materials1982-11-10