FDA.reportPublic FDA data

510(k) K874050

Device
INFLATABLE FOOT & ANKLE SPLINT
Applicant
VINYL TECHNOLOGY, INC.
510(k) number
K874050
Product code
FZF  
Decision
Substantially Equivalent (SESE)
Decision date
1987-11-23
Date received
1987-10-05
Regulation
878.3900
Classification name
Splint, Extremity, Inflatable, External
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CARLOS A MOLLURA
Address
2110 Edwards Ave. So. El Monte CA US 91733 91733

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FZF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K881516COMPRESAIDR. Evans Corp.1988-04-29
K874051INFLATABLE FULL LEG SPLINTVinyl Technology, Inc.1987-11-23
K874052INFLATABLE HALF LEG SPLINTVinyl Technology, Inc.1987-11-23
K874053INFLATABLE FULL ARM SPLINTVinyl Technology, Inc.1987-11-23
K853600INFLATABLE AIR SPLINTSHospitak, Inc.1985-09-19
K831764URIAS PRESSURE SPLINTS, & FIRST AIDSvenol Andersen1983-09-12

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases