ECHOTIP(R) ULTRA FIDUCIAL NEEDLE


Device Classification Name

marker, radiographic, implantable

510(k) Number K111895
Device Name ECHOTIP(R) ULTRA FIDUCIAL NEEDLE
Applicant
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY
4900 bethania station road
winston-salem, 
NC 
27105

Applicant Contact marge walls-walker
Correspondent
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY
4900 bethania station road
winston-salem, 
NC 
27105

Correspodent Contact marge walls-walker
Regulation Number 878.4300
Classification Product Code
NEU  
Subsequent Product Code
FCG  
Date Received 07/05/2011
Decision Date 04/27/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No