Device Classification Name |
suture, nonabsorbable, steel, monofilament and multifilament, sterile
|
510(k) Number |
K984151 |
Device Name |
STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP |
Applicant |
MILL POND, INC. |
ONE STILES ROAD, SUITE 104 |
SALEM,
NH
03079
|
|
Applicant Contact |
GREGORY E SANCOFF |
Correspondent |
MILL POND, INC. |
ONE STILES ROAD, SUITE 104 |
SALEM,
NH
03079
|
|
Correspondent Contact |
GREGORY E SANCOFF |
Regulation Number | 878.4495
|
Classification Product Code |
|
Date Received | 11/19/1998 |
Decision Date | 04/28/1999 |
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
|
|
|