Device Classification Name |
Needle, Conduction, Anesthetic (W/Wo Introducer)
|
510(k) Number |
K911221 |
Device Name |
ATRAUMATIC SPECIAL SPROTTE NEEDLE |
Applicant |
PAJUNK GMBH |
WASHINGTON SQUARE SUITE 1100 |
1050 CONNECTICUT AVENUE N.W. |
WASHINGTON,
DC
20036
|
|
Applicant Contact |
BRUCE MACKLER |
Correspondent |
PAJUNK GMBH |
WASHINGTON SQUARE SUITE 1100 |
1050 CONNECTICUT AVENUE N.W. |
WASHINGTON,
DC
20036
|
|
Correspondent Contact |
BRUCE MACKLER |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 03/19/1991 |
Decision Date | 07/24/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|