Device Classification Name |
Needle, Conduction, Anesthetic (W/Wo Introducer)
|
510(k) Number |
K090261 |
Device Name |
PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G |
Applicant |
SMITHS MEDICAL ASD, INC. |
10 BOWMAN DR. |
KEENE,
NH
03431
|
|
Applicant Contact |
CINDY ENGELHARDT |
Correspondent |
SMITHS MEDICAL ASD, INC. |
10 BOWMAN DR. |
KEENE,
NH
03431
|
|
Correspondent Contact |
CINDY ENGELHARDT |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 02/03/2009 |
Decision Date | 05/01/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|