Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K210584 |
Device Name |
SDC3 HD Information Management System with Wireless Device Control Capability |
Applicant |
Stryker |
5900 Optical Ct |
San Jose,
CA
95138
|
|
Applicant Contact |
Divya Sekar |
Correspondent |
Stryker |
5900 Optical Ct |
San Jose,
CA
95138
|
|
Correspondent Contact |
Divya Sekar |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/26/2021 |
Decision Date | 03/18/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|