Device Classification Name |
media, coupling, ultrasound
|
510(k) Number |
K102683 |
Device Name |
THE ADDITION |
Applicant |
OB THE-ADDITION, LLC |
2206 MODOC ROAD #3 |
SANTA BARBARA,
CA
93101
|
|
Applicant Contact |
Rebecca K Pine |
Correspondent |
OB THE-ADDITION, LLC |
2206 MODOC ROAD #3 |
SANTA BARBARA,
CA
93101
|
|
Correspondent Contact |
Rebecca K Pine |
Regulation Number | 892.1570
|
Classification Product Code |
|
Date Received | 09/17/2010 |
Decision Date | 01/06/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|