Device Classification Name |
Stimulator, Nerve, Battery-Powered
|
510(k) Number |
K070134 |
Device Name |
MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 |
Applicant |
STOCKERT GMBH |
BOETZINGER STRASSE 72 |
FREIBURG, B-W,
DE
D-79111
|
|
Applicant Contact |
DOMINIKA SCHULER |
Correspondent |
STOCKERT GMBH |
BOETZINGER STRASSE 72 |
FREIBURG, B-W,
DE
D-79111
|
|
Correspondent Contact |
DOMINIKA SCHULER |
Regulation Number | 868.2775
|
Classification Product Code |
|
Date Received | 01/16/2007 |
Decision Date | 03/22/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|