MAMMOSITE CAVITY EVALUATION DEVICE


Device Classification Name

system, applicator, radionuclide, remote-controlled

510(k) Number K081179
Device Name MAMMOSITE CAVITY EVALUATION DEVICE
Applicant
HOLOGIC, INC.
250 campus drive
marlborough, 
MA 
01752

Applicant Contact randall j covill
Regulation Number 892.5700
Classification Product Code
JAQ  
Subsequent Product Code
MWZ  
Date Received 04/25/2008
Decision Date 05/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No