| 510(k) Number |
K920240 |
| Device Name |
SOLUMBRA SUN PROTECTIVE CLOTHING |
| Applicant |
| Wetmore Assoc., Inc. |
| 310 W. Prospect St. |
|
Seattle,
WA
98119
|
|
| Applicant Contact |
HUGHES |
| Correspondent |
| Wetmore Assoc., Inc. |
| 310 W. Prospect St. |
|
Seattle,
WA
98119
|
|
| Correspondent Contact |
HUGHES |
| Classification Product Code |
|
| Date Received | 01/17/1992 |
| Decision Date | 05/13/1992 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|