Device Classification Name |
anesthesia conduction kit
|
510(k) Number |
K043130 |
Device Name |
MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS |
Applicant |
PAJUNK GMBH |
5101 NW CRESCENT VALLEY DR. |
CORVALLIS,
OR
97330
|
|
Applicant Contact |
BURK A BRANDT |
Correspondent |
PAJUNK GMBH |
5101 NW CRESCENT VALLEY DR. |
CORVALLIS,
OR
97330
|
|
Correspondent Contact |
BURK A BRANDT |
Regulation Number | 868.5140
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/12/2004 |
Decision Date | 12/21/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|