Device Classification Name |
Needle, Conduction, Anesthetic (W/Wo Introducer)
|
510(k) Number |
K191290 |
Device Name |
Ancora Nerve Block Catheter Set |
Applicant |
Ancora Medical Technology |
333 Ravenswood Ave |
Menlo Park,
CA
94025
|
|
Applicant Contact |
Chunyuan Qiu |
Correspondent |
Decus Biomedical Inc |
2342 Shattuck Ave #333 |
Berkeley,
CA
94704
|
|
Correspondent Contact |
Terri Bogucki |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 05/13/2019 |
Decision Date | 02/06/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|