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510(k) K952350

Device
JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)
Applicant
PROMEDICAL LTD.
510(k) number
K952350
Product code
LWE  
Decision
Substantially Equivalent (SESE)
Decision date
1995-07-17
Date received
1995-05-19
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
HENRY V SIERAKOWSKI
Address
240 Braen Ave. Wyckoff NJ US 07481 07481

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
K913306BONE-TEMNO/STERNUM-TEMNOProact, Ltd.1991-11-01
K871198BONE MARROW COLLECTION KIT AND STANDBaxter Healthcare Corp1987-11-06

Legacy Summary#

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FDA Review#

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