Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K172937 |
Device Name |
Colorado Therapeutics Xenograft Implant |
Applicant |
Colorado Therapeutics LLC |
2150 West 6th Avenue, Suite L |
Bloomfield,
CA
80020
|
|
Applicant Contact |
William Jackson |
Correspondent |
Colorado Therapeutics LLC |
2150 West 6th Avenue, Suite L |
Bloomfield,
CA
80020
|
|
Correspondent Contact |
William Jackson |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/26/2017 |
Decision Date | 10/25/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|