Device Classification Name |
suture, nonabsorbable, silk
|
510(k) Number |
K160623 |
Device Name |
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture |
Applicant |
M/S. MERIL ENDO SURGERY PRIVATE LIMITED |
3FL, E1-E3, MERIL PARK, SURVEY NO. 135/2/B & 174/2, |
MUKTANAND MARG |
Chala, Vapi,
IN
396191
|
|
Applicant Contact |
Umesh Sharma |
Correspondent |
M/S. MERIL ENDO SURGERY PRIVATE LIMITED |
3FL, E1-E3, MERIL PARK, SURVEY NO. 135/2/B & 174/2, |
MUKTANAND MARG |
Chala, Vapi,
IN
396191
|
|
Correspondent Contact |
Umesh Sharma |
Regulation Number | 878.5030
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/04/2016 |
Decision Date | 05/31/2016 |
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
|
|
|