Device Classification Name |
needle, conduction, anesthetic (w/wo introducer)
|
510(k) Number |
K011122 |
Device Name |
BALLPEN SPINAL NEEDLE W/WO INTRODUCER |
Applicant |
RUSCH INTL. |
50 PLANTATION DR. |
JAFFERY,
NH
03452
|
|
Applicant Contact |
JULIE A BEAUMONT |
Correspondent |
RUSCH INTL. |
50 PLANTATION DR. |
JAFFERY,
NH
03452
|
|
Correspondent Contact |
JULIE A BEAUMONT |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 04/12/2001 |
Decision Date | 11/16/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|