Device Classification Name |
ophthalmic syringe
|
510(k) Number |
K200242 |
Device Name |
StaClear Syringe |
Applicant |
TriboFilm Research, Inc. |
625 Hutton Street |
Raleigh,
NC
27606
|
|
Applicant Contact |
Jackson Thornton |
Correspondent |
NAMSA |
400 Highway 169 South, Suite 500 |
Minneapolis,
MN
55426
|
|
Correspondent Contact |
Beryl St. Jeanne |
Regulation Number | 880.5860
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/31/2020 |
Decision Date | 07/27/2020 |
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
|
|
|