Device Classification Name |
anesthesia conduction kit
|
510(k) Number |
K060563 |
Device Name |
EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV |
Applicant |
PAJUNK GMBH |
KARL-HALL-STRASSE 1 |
GEISINGEN,
DE
D-78187
|
|
Applicant Contact |
CHRISTAIN QUASS |
Correspondent |
PAJUNK GMBH |
KARL-HALL-STRASSE 1 |
GEISINGEN,
DE
D-78187
|
|
Correspondent Contact |
CHRISTAIN QUASS |
Regulation Number | 868.5140
|
Classification Product Code |
|
Date Received | 02/08/2006 |
Decision Date | 06/02/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|