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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mammographic
510(k) Number K073262
Device Name BELLA
Applicant
BEEKLEY CORP.
150 DOLPHIN RD.
BRISTOL,  CT  06011
Applicant Contact MARTINE M BOUTTE
Correspondent
BEEKLEY CORP.
150 DOLPHIN RD.
BRISTOL,  CT  06011
Correspondent Contact MARTINE M BOUTTE
Regulation Number892.1710
Classification Product Code
IZH  
Date Received11/20/2007
Decision Date 03/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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