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 Number | 892.1710
|
Classification Product Code |
|
Date Received | 02/26/2002 |
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
|
|
|