Device Classification Name |
suture, nonabsorbable, synthetic, polyethylene
|
510(k) Number |
K153746 |
Device Name |
Dunamis Force DFX Tensile Tape |
Applicant |
Dunamis LLC |
693 Sherling Lake Rd. Apt. 122 |
Greenville,
AL
36037
|
|
Applicant Contact |
Prithvi Raj Chavan |
Correspondent |
Compliance Systems International, LLC |
1083 Delaware Ave. |
Buffalo,
NY
14209
|
|
Correspondent Contact |
Robert O Dean |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 12/29/2015 |
Decision Date | 03/03/2016 |
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
|