| Device Classification Name |
Dressing, Wound, Drug
|
| 510(k) Number |
K051542 |
| Device Name |
TRIOSYN T40 ANTIMICROBIAL WOUND DRESSING |
| Applicant |
| Triosyn Corp. |
| 1191 S. Brownell Rd. |
|
Williston,
VT
05495
|
|
| Applicant Contact |
KYLE ANDERSON |
| Correspondent |
| Triosyn Corp. |
| 1191 S. Brownell Rd. |
|
Williston,
VT
05495
|
|
| Correspondent Contact |
KYLE ANDERSON |
| Classification Product Code |
|
| Date Received | 06/10/2005 |
| Decision Date | 03/17/2006 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
Yes
|
Predetermined Change Control Plan Authorized |
No
|
|
|