Device Classification Name |
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
|
510(k) Number |
K910067 |
Device Name |
PTI STERNAL CLOSURE WIRE SUTURE |
Applicant |
PIONEERING TECHNOLOGIES, INC. |
3900 YOUNGFIELD ST. |
WHEAT RIDGE,
CO
80033
|
|
Applicant Contact |
WRIGHT |
Correspondent |
PIONEERING TECHNOLOGIES, INC. |
3900 YOUNGFIELD ST. |
WHEAT RIDGE,
CO
80033
|
|
Correspondent Contact |
WRIGHT |
Regulation Number | 878.4495
|
Classification Product Code |
|
Date Received | 01/09/1991 |
Decision Date | 05/06/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|