| Device Classification Name |
Anesthesia Conduction Kit
|
| 510(k) Number |
K014246 |
| Device Name |
AVID-NIT NERVE STIMULATION NEEDLES |
| Applicant |
| Avid N.I.T., Inc. |
| 390 Scarlet Blvd. |
|
Oldsmar,
FL
34677
|
|
| Applicant Contact |
SCOTT HENDERSON |
| Correspondent |
| Avid N.I.T., Inc. |
| 390 Scarlet Blvd. |
|
Oldsmar,
FL
34677
|
|
| Correspondent Contact |
SCOTT HENDERSON |
| Regulation Number | 868.5140 |
| Classification Product Code |
|
| Subsequent Product Code |
|
| Date Received | 12/26/2001 |
| Decision Date | 07/16/2002 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|