DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE


information about

Device Classification Name

endoscopic injection needle, gastroenterology-urology

510(k) Number K000646
Device Name DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE
Original Applicant
ENTERIC MEDICAL TECHNOLOGIES
1125 east hillsdale blvd.
suite 106
foster city, 
CA 
94404

Original Contact jill m visor
Regulation Number 876.1500
Classification Product Code
FBK  
Date Received 02/25/2000
Decision Date 04/13/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No