LBS-63-16 BREAST ARRAY COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K072873
Device Name LBS-63-16 BREAST ARRAY COIL
Applicant
INVIVO
3545 s.w. 47th ave.
gainesville, 
FL 
32608

Applicant Contact jeff wilkinson
Correspondent
INVIVO
3545 s.w. 47th ave.
gainesville, 
FL 
32608

Correspodent Contact jeff wilkinson
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 10/09/2007
Decision Date 11/16/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Special
Reviewed by Third Party No

Combination Product

No