FDA.reportPublic FDA data

510(k) K904389

Device
SI-PRO
Applicant
DAVID F. TRUNGALE
510(k) number
K904389
Product code
EYF  
Decision
Substantially Equivalent (SESE)
Decision date
1990-12-17
Date received
1990-09-26
Regulation
510(k) Premarket Notification
Classification name
Protector, Wound, Plastic
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DAVID F TRUNAGLE
Address
16720 Rosewood Ct. Brookfield WI US 53005 53005

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EYF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K922785IRRIVAGEAutovage1992-10-16
K911407HARDING STERNAL SHIELDHarding Medical Devices1991-07-05
K910104ANTI-FOG DISPOSABLE IV INDUCTION COVERCentral Plastic, Inc.1991-04-12
K832908COMFEEL PROTECTIVE RINGSColoplast A/S1983-12-12

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