Device Classification Name |
Anesthesia Conduction Kit
|
510(k) Number |
K222341 |
Device Name |
Arrow 0.2 Micron Flat Filter, GVS |
Applicant |
Arrow International, LLC |
3015 Carrington Mill Blvd |
Morrisville,
NC
27560
|
|
Applicant Contact |
Ann Metz |
Correspondent |
Arrow International, LLC |
3015 Carrington Mill Blvd |
Morrisville,
NC
27560
|
|
Correspondent Contact |
Ann Metz |
Regulation Number | 868.5140
|
Classification Product Code |
|
Date Received | 08/03/2022 |
Decision Date | 02/13/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|