RADIOACTIVE SEED LOCALIZATION NEEDLE


Device Classification Name

source, brachytherapy, radionuclide

510(k) Number K111979
Device Name RADIOACTIVE SEED LOCALIZATION NEEDLE
Applicant
BIOCOMPATIBLES INC.
115 hurley rd bldg 3f
oxford, 
CT 
06478

Applicant Contact wayne richardson
Correspondent
BIOCOMPATIBLES INC.
115 hurley rd bldg 3f
oxford, 
CT 
06478

Correspodent Contact wayne richardson
Regulation Number 892.5730
Classification Product Code
KXK  
Date Received 07/12/2011
Decision Date 10/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No