Device Classification Name |
needle, conduction, anesthetic (w/wo introducer)
|
510(k) Number |
K013892 |
Device Name |
LUTZ NEEDLE |
Applicant |
BALLARD MEDICAL PRODUCTS |
12050 LONE PEAK PKWY. |
DRAPER,
UT
84020
|
|
Applicant Contact |
SYDNEE F MCMILLAN |
Correspondent |
BALLARD MEDICAL PRODUCTS |
12050 LONE PEAK PKWY. |
DRAPER,
UT
84020
|
|
Correspondent Contact |
SYDNEE F MCMILLAN |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 11/23/2001 |
Decision Date | 07/11/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|