Device Classification Name |
Needle, Conduction, Anesthetic (W/Wo Introducer)
|
510(k) Number |
K972595 |
Device Name |
ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER |
Applicant |
AVID N.I.T., INC. |
917 KLOSTERMAN RD. EAST |
TARPON SPRINGS,
FL
34689
|
|
Applicant Contact |
JOSEPH E HARMS |
Correspondent |
AVID N.I.T., INC. |
917 KLOSTERMAN RD. EAST |
TARPON SPRINGS,
FL
34689
|
|
Correspondent Contact |
JOSEPH E HARMS |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 07/11/1997 |
Decision Date | 05/20/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|