| Device Classification Name |
Fiber, Medical, Absorbent
|
| 510(k) Number |
K110715 |
| Device Name |
INTERDRY SILVER |
| Applicant |
| Milliken Healthcare Products, LLC |
| 920 Milliken Rd. |
|
Spartanburg,
SC
29303
|
|
| Applicant Contact |
BRIAN J LINDSAY |
| Correspondent |
| Milliken Healthcare Products, LLC |
| 920 Milliken Rd. |
|
Spartanburg,
SC
29303
|
|
| Correspondent Contact |
BRIAN J LINDSAY |
| Regulation Number | 880.5300 |
| Classification Product Code |
|
| Date Received | 03/15/2011 |
| Decision Date | 11/04/2011 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|