FDA.reportPublic FDA data

510(k) K905838

Device
STRATO PORT INTRODUCER KT(10 FR) LPS 5015/MODIFIED
Applicant
STRATO MEDICAL CORP.
510(k) number
K905838
Product code
LST  
Decision
Substantially Equivalent - Kit (SESK)
Decision date
1991-04-19
Date received
1990-12-27
Regulation
510(k) Premarket Notification
Classification name
Device, Erectile Dysfunction
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
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
NANCY C HALL
Address
123 Brimbal Ave. P.O.B.3148 Beverly MA US 01915 01915

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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