| 510(k) Number |
K853847 |
| Device Name |
SUPER MICRO BLADES |
| Applicant |
| Kdans Surgical, Inc. |
| 109 Clifton Rd. |
|
Cynthiana,
KY
41031
|
|
| Applicant Contact |
KANU SKUKLA |
| Correspondent |
| Kdans Surgical, Inc. |
| 109 Clifton Rd. |
|
Cynthiana,
KY
41031
|
|
| Correspondent Contact |
KANU SKUKLA |
| Date Received | 09/16/1985 |
| Decision Date | 10/15/1985 |
| 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
|
|
|