| Device Classification Name |
Bath, Paraffin
|
| 510(k) Number |
K022626 |
| Device Name |
MOISTURESTAY (REVLON) |
| Applicant |
| Raymond Industrial, Ltd. |
| 972 Weedon Dr. NE |
|
Saint Petersburg,
FL
33702
|
|
| Applicant Contact |
ROBERT T WAGNER |
| Correspondent |
| Raymond Industrial, Ltd. |
| 972 Weedon Dr. NE |
|
Saint Petersburg,
FL
33702
|
|
| Correspondent Contact |
ROBERT T WAGNER |
| Regulation Number | 890.5110 |
| Classification Product Code |
|
| Date Received | 08/07/2002 |
| Decision Date | 10/29/2002 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|