Device Classification Name |
Anesthesia Conduction Kit
|
510(k) Number |
K113188 |
Device Name |
SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG |
Applicant |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
KARL-HALL-STRASSE 1 |
GEISINGEN,
DE
78187
|
|
Applicant Contact |
CHRISTIAN G QUASS |
Correspondent |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
KARL-HALL-STRASSE 1 |
GEISINGEN,
DE
78187
|
|
Correspondent Contact |
CHRISTIAN G QUASS |
Regulation Number | 868.5140
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/31/2011 |
Decision Date | 03/01/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|