Device Classification Name |
stimulator, nerve, battery-powered
|
510(k) Number |
K021033 |
Device Name |
STIMUPLEX-DIG-RC NERVE STIMULATOR |
Applicant |
B. BRAUN MEDICAL, INC. |
901 MARCON BLVD. |
ALLENTOWN,
PA
18109 -9341
|
|
Applicant Contact |
SHERI L MUSGNUNG |
Correspondent |
B. BRAUN MEDICAL, INC. |
901 MARCON BLVD. |
ALLENTOWN,
PA
18109 -9341
|
|
Correspondent Contact |
SHERI L MUSGNUNG |
Regulation Number | 868.2775
|
Classification Product Code |
|
Date Received | 03/29/2002 |
Decision Date | 03/21/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|