Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyethylene
|
510(k) Number |
K150327 |
Device Name |
Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 |
Applicant |
Dunamis LLC |
693 Sherling Lake Rd. |
Greenville,
AL
36037
|
|
Applicant Contact |
Prithviraj Chavan |
Correspondent |
LEXAMED |
705 FRONT ST. |
TOLEDO,
OH
43605
|
|
Correspondent Contact |
Robert O Dean |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 02/10/2015 |
Decision Date | 06/29/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|