| Device Classification Name |
Tape And Bandage, Adhesive
|
| 510(k) Number |
K952606 |
| Device Name |
TARGETT PATCH |
| Applicant |
| Cutting Edge Technologies, Inc. |
| 11 Roselawn Ln. |
|
Malvern,
PA
19355
|
|
| Applicant Contact |
GEORGE H MYERS |
| Correspondent |
| Cutting Edge Technologies, Inc. |
| 11 Roselawn Ln. |
|
Malvern,
PA
19355
|
|
| Correspondent Contact |
GEORGE H MYERS |
| Regulation Number | 880.5240 |
| Classification Product Code |
|
| Date Received | 06/06/1995 |
| Decision Date | 12/21/1995 |
| 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
|
|
|