| Device Classification Name |
Stimulator, Neuromuscular, External Functional
|
|---|
| 510(k) Number |
K090750 |
|---|
| Device Name |
RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 |
|---|
| Applicant |
| Restorative Therapies, Inc. |
| 907 S. Lakewood Ave. |
|
Baltimore,
MD
21224
|
|
| Applicant Contact |
ANDREW BARRISKILL |
| Correspondent |
| Restorative Therapies, Inc. |
| 907 S. Lakewood Ave. |
|
Baltimore,
MD
21224
|
|
| Correspondent Contact |
ANDREW BARRISKILL |
| Regulation Number | 882.5810 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 03/20/2009 |
|---|
| Decision Date | 08/05/2009 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Neurology
|
|---|
| 510k Review Panel |
Neurology
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|