Device Classification Name |
block, beam-shaping, radiation therapy
|
510(k) Number |
K132236 |
Device Name |
.DECIMAL PROTON APERTURE |
Applicant |
.DECIMAL, INC. |
121 CENTRAL PARK PLACE |
SANFORD,
FL
32771
|
|
Applicant Contact |
KIMBERLY RUPP |
Correspondent |
.DECIMAL, INC. |
121 CENTRAL PARK PLACE |
SANFORD,
FL
32771
|
|
Correspondent Contact |
KIMBERLY RUPP |
Regulation Number | 892.5710
|
Classification Product Code |
|
Date Received | 07/18/2013 |
Decision Date | 10/16/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|