Device Classification Name |
stimulator, muscle, powered
|
510(k) Number |
K926084 |
Device Name |
HVGS 9000 |
Applicant |
SHEVLIN MEDICAL, INC. |
5416 MILL RUN DR. |
MCKINNEY,
TX
75069
|
|
Applicant Contact |
DANIEL SHEVLIN |
Correspondent |
SHEVLIN MEDICAL, INC. |
5416 MILL RUN DR. |
MCKINNEY,
TX
75069
|
|
Correspondent Contact |
DANIEL SHEVLIN |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 12/02/1992 |
Decision Date | 03/14/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|