EXTENSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

AMES TDA/GENTGMICIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BD Vaginal Panel

FDA 510(k)

FDA Class 2 ·Microbiology

CAVOMAT

FDA 510(k)

FDA Class 2 ·Physical Medicine

RAZEL MODEL C

FDA 510(k)

FDA Class 2 ·General Hospital

PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KIRSCHNER PERFORM TOTAL KNEE SYSTEM POROUS COATED

FDA 510(k)

FDA Class 2 ·Orthopedic

ASAHI BLOOD/PLASMA PUMP #ABP-01A &

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TOWNLEY TOTAL KNEE (TTK)

FDA 510(k)

FDA Class 2 ·Orthopedic

CSI/QCT

FDA 510(k)

FDA Class 2 ·Radiology

POINTE 750 GLYCOMETER

FDA 510(k)

FDA Class 2 ·Hematology

ADC QS/IPD WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System

FDA 510(k)

FDA Class 2 ·General Hospital

PRESSURE MONITORING IV BOTTLE CAP

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLIRANS TAF06 HOLLOW FIBER DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

MatriStem UBM Pericardial Patch

FDA 510(k)

FDA Class 2 ·Cardiovascular

TISSUE INTEGRATED PROSTHESIS DRILL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NEW JERSEY ACETABULAR COMPONENT &

FDA 510(k)

FDA Class 2 ·Orthopedic

MICRODOSE POTASSIUM OXYLATE

FDA 510(k)

FDA Class 2 ·Dental