Device Classification Name |
Needle, Conduction, Anesthetic (W/Wo Introducer)
|
510(k) Number |
K063350 |
Device Name |
DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE |
Applicant |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
KARL-HALL-STRASSE 01 |
GEISINGEN, BADEN-WURTTEMBERG,
DE
78187
|
|
Applicant Contact |
CHRISTIAN QUASS |
Correspondent |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
KARL-HALL-STRASSE 01 |
GEISINGEN, BADEN-WURTTEMBERG,
DE
78187
|
|
Correspondent Contact |
CHRISTIAN QUASS |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 11/06/2006 |
Decision Date | 02/01/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|