ENCIRCLE LOCALIZATION DEVICE


Device Classification Name

instrument, biopsy

510(k) Number K022286
Device Name ENCIRCLE LOCALIZATION DEVICE
Original Applicant
VIVANT MEDICAL, INC.
1916-a old middlefield way
mountain view, 
CA 
94043

Original Contact steven kim
Regulation Number 876.1075
Classification Product Code
KNW  
Date Received 07/15/2002
Decision Date 10/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No