Device Classification Name |
Catheter, Conduction, Anesthetic
|
510(k) Number |
K991259 |
Device Name |
TE ME NA EPIDURAL CATHETER |
Applicant |
TE ME NA S.A.R.L. |
390 SCARLET BLVD. |
OLDSMAR,
FL
34677
|
|
Applicant Contact |
JOE HARMS |
Correspondent |
TE ME NA S.A.R.L. |
390 SCARLET BLVD. |
OLDSMAR,
FL
34677
|
|
Correspondent Contact |
JOE HARMS |
Regulation Number | 868.5120
|
Classification Product Code |
|
Date Received | 04/13/1999 |
Decision Date | 02/21/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|