FDA.reportPublic FDA data

510(k) K913306

Device
BONE-TEMNO/STERNUM-TEMNO
Applicant
PROACT, LTD.
510(k) number
K913306
Product code
LWE  
Decision
Substantially Equivalent (SESE)
Decision date
1991-11-01
Date received
1991-07-25
Regulation
510(k) Premarket Notification
Classification name
Bone Marrow Collection/transfusion Kit
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 Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOSEPH M LOONEY
Address
Calder Sq. Box 11029 State College PA US 16805 16805

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LWE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K952350JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)Promedical , Ltd.1995-07-17
K871198BONE MARROW COLLECTION KIT AND STANDBaxter Healthcare Corp1987-11-06

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