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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 K020624
Device Name BREAST BOLSTER
Applicant
Beekley Corp.
Prestige Ln.
Bristol,  CT  06010
Applicant Contact MAEGHAN E ARCHAMBAULT
Correspondent
Beekley Corp.
Prestige Ln.
Bristol,  CT  06010
Correspondent Contact MAEGHAN E ARCHAMBAULT
Regulation Number892.1710
Classification Product Code
IZH  
Date Received02/26/2002
Decision Date 09/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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