Device Classification Name |
suture, nonabsorbable, silk
|
510(k) Number |
K071111 |
Device Name |
NON-ABSORBABLE SILK SUTURE |
Applicant |
ARROW INTL., INC. |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Applicant Contact |
KARL J NITTINGER |
Correspondent |
ARROW INTL., INC. |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Correspondent Contact |
KARL J NITTINGER |
Regulation Number | 878.5030
|
Classification Product Code |
|
Date Received | 04/20/2007 |
Decision Date | 07/17/2007 |
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
|