Device Classification Name |
sterilization wrap containers, trays, cassettes & other accessories
|
510(k) Number |
K200858 |
Device Name |
Mini Sterilizable Tray |
Applicant |
Implant Direct Sybron Manufacturing, LLC |
3050 East Hillcrest Drive |
Thousand Oaks,
CA
91362
|
|
Applicant Contact |
Reina Choi |
Correspondent |
Implant Direct Sybron Manufacturing, LLC |
3050 East Hillcrest Drive |
Thousand Oaks,
CA
91362
|
|
Correspondent Contact |
Reina Choi |
Regulation Number | 880.6850
|
Classification Product Code |
|
Date Received | 04/01/2020 |
Decision Date | 08/06/2020 |
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
|
|
|