| Device Classification Name |
Needle, Conduction, Anesthetic (W/Wo Introducer)
|
| 510(k) Number |
K923003 |
| Device Name |
PAJUNK STANDARD SPROTTE NEEDLE W/ INTRODUCER CANN. |
| Applicant |
| Rusch, Inc. |
| Tall Pines Park |
|
Jeffrey,
NH
03452
|
|
| Applicant Contact |
RICHARD T LYKINS |
| Correspondent |
| Rusch, Inc. |
| Tall Pines Park |
|
Jeffrey,
NH
03452
|
|
| Correspondent Contact |
RICHARD T LYKINS |
| Regulation Number | 868.5150 |
| Classification Product Code |
|
| Date Received | 06/22/1992 |
| Decision Date | 04/15/1993 |
| 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
|
|
|