INTRABEAM NEEDLE APPLICATOR


Device Classification Name

system, therapeutic, x-ray

510(k) Number K110590
Device Name INTRABEAM NEEDLE APPLICATOR
Applicant
CARL ZEISS SURGICAL GMBH
5160 hacienda drive
dublin, 
CA 
94568

Applicant Contact judith a brimacombe, ma
Correspondent
CARL ZEISS SURGICAL GMBH
5160 hacienda drive
dublin, 
CA 
94568

Correspodent Contact judith a brimacombe, ma
Regulation Number 892.5900
Classification Product Code
JAD  
Date Received 03/02/2011
Decision Date 04/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No