Device Classification Name |
syringe, piston
|
510(k) Number |
K202432 |
Device Name |
MiniLoad Syringe |
Applicant |
OcuJect, LLC |
1441 Avocado Ave, Suite 204 |
Newport Beach,
CA
92660
|
|
Applicant Contact |
Rebecca K Pine |
Correspondent |
OcuJect, LLC |
1441 Avocado Ave, Suite 204 |
Newport Beach,
CA
92660
|
|
Correspondent Contact |
Rebecca K Pine |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 08/25/2020 |
Decision Date | 02/19/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|