Device Classification Name |
suture, nonabsorbable, steel, monofilament and multifilament, sterile
|
510(k) Number |
K141007 |
Device Name |
DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE |
Applicant |
DEMETECH CORP. |
14175 NW 60th Ave |
Miami Lakes,
FL
33014
|
|
Applicant Contact |
ANTHONY DIMERCURIO |
Correspondent |
DEMETECH CORP. |
14175 NW 60th Ave |
Miami Lakes,
FL
33014
|
|
Correspondent Contact |
ANTHONY DIMERCURIO |
Regulation Number | 878.4495
|
Classification Product Code |
|
Date Received | 04/18/2014 |
Decision Date | 09/25/2014 |
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
|