Device Classification Name |
Clamp, Surgical, General & Plastic Surgery
|
510(k) Number |
K153358 |
Device Name |
Standard Clamp |
Applicant |
STANDARD BARIATRICS |
4362 GLENDALE MILFORD RD. |
CINCINNATI,
OH
45242
|
|
Applicant Contact |
ALISON SATHE |
Correspondent |
STANDARD BARIATRICS |
4362 GLENDALE MILFORD RD. |
CINCINNATI,
OH
45242
|
|
Correspondent Contact |
ALISON SATHE |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 11/20/2015 |
Decision Date | 05/02/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|