Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyethylene
|
510(k) Number |
K033654 |
Device Name |
FORCE FIBER |
Applicant |
TELEFLEX MEDICAL |
600 AIRPORT RD. |
FALL RIVER,
MA
02720 -4740
|
|
Applicant Contact |
LYNN MATOS |
Correspondent |
TELEFLEX MEDICAL |
600 AIRPORT RD. |
FALL RIVER,
MA
02720 -4740
|
|
Correspondent Contact |
LYNN MATOS |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 11/21/2003 |
Decision Date | 01/15/2004 |
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
|
|
|