Device Classification Name |
needle, conduction, anesthetic (w/wo introducer)
|
510(k) Number |
K061394 |
Device Name |
SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE) |
Applicant |
BUSSE HOSPITAL DISPOSABLES, INC. |
75 ARKAY DRIVE |
P.O. BOX 11067 |
HAUPPAUGE,
NY
11788
|
|
Applicant Contact |
MUHAMAD ANSARI |
Correspondent |
BUSSE HOSPITAL DISPOSABLES, INC. |
75 ARKAY DRIVE |
P.O. BOX 11067 |
HAUPPAUGE,
NY
11788
|
|
Correspondent Contact |
MUHAMAD ANSARI |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 05/19/2006 |
Decision Date | 09/06/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|