| Device Classification Name |
Pad, Heating, Powered
|
|---|
| 510(k) Number |
K072534 |
|---|
| Device Name |
BIO-MAT 2000 |
|---|
| Applicant |
| RICHWAY INTL., INC. |
| 1314 SOUTH KING ST., SUITE 520 |
|
HONOLULU,
HI
96814
|
|
| Applicant Contact |
LEROY KLIMA |
| Correspondent |
| RICHWAY INTL., INC. |
| 1314 SOUTH KING ST., SUITE 520 |
|
HONOLULU,
HI
96814
|
|
| Correspondent Contact |
LEROY KLIMA |
| Regulation Number | 890.5740
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 09/07/2007 |
|---|
| Decision Date | 02/08/2008 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Physical Medicine
|
|---|
| 510k Review Panel |
Physical Medicine
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|