Device Classification Name |
Catheter, Conduction, Anesthetic
|
510(k) Number |
K093920 |
Device Name |
BUSSE EPIDURAL CATHETER KIT |
Applicant |
BUSSE HOSPITAL DISPOSABLES |
75 ARKAY DRIVE |
HAUPPAUGE,
NY
11788
|
|
Applicant Contact |
MUHAMAD ANSARI |
Correspondent |
BUSSE HOSPITAL DISPOSABLES |
75 ARKAY DRIVE |
HAUPPAUGE,
NY
11788
|
|
Correspondent Contact |
MUHAMAD ANSARI |
Regulation Number | 868.5120
|
Classification Product Code |
|
Date Received | 12/22/2009 |
Decision Date | 08/06/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|