Device Classification Name |
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
|
510(k) Number |
K193603 |
Device Name |
Benesta Medical Sterilization Tray |
Applicant |
Caldera Medical, Inc |
5171 Clareton Drive |
Agoura Hills,
CA
91301
|
|
Applicant Contact |
Vicki Gail |
Correspondent |
Caldera Medical, Inc |
5171 Clareton Drive |
Agoura Hills,
CA
91301
|
|
Correspondent Contact |
Vicki Gail |
Regulation Number | 880.6850
|
Classification Product Code |
|
Date Received | 12/23/2019 |
Decision Date | 07/20/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|