| Device Classification Name |
Strip, Adhesive, Closure, Skin
|
| 510(k) Number |
K833258 |
| Device Name |
SKIN TECH. SURGI-STRIPS |
| Applicant |
| LEE TEC CORP. |
| 803 N. Front St. Suite 3 |
|
McHenry,
IL
60050
|
|
| Correspondent |
| LEE TEC CORP. |
| 803 N. Front St. Suite 3 |
|
McHenry,
IL
60050
|
|
| Regulation Number | 880.5240 |
| Classification Product Code |
|
| Date Received | 09/20/1983 |
| Decision Date | 01/25/1984 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|