Device Classification Name |
Counter, Sponge, Surgical
|
510(k) Number |
K121274 |
Device Name |
PIXEL APP |
Applicant |
GAUSS SURGICAL, INC. |
22700 ALCALDE RD |
CUPERTINO,
CA
95014
|
|
Applicant Contact |
PEGGY MCLAUGHLIN |
Correspondent |
GAUSS SURGICAL, INC. |
22700 ALCALDE RD |
CUPERTINO,
CA
95014
|
|
Correspondent Contact |
PEGGY MCLAUGHLIN |
Regulation Number | 880.2740
|
Classification Product Code |
|
Date Received | 04/27/2012 |
Decision Date | 06/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|