Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyethylene
|
510(k) Number |
K063778 |
Device Name |
FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE |
Applicant |
TELEFLEX MEDICAL |
2345 WAUKEGAN ROAD |
SUITE 120 |
BANNOCKBURN,
IL
60015
|
|
Applicant Contact |
LORI HAYS |
Correspondent |
TELEFLEX MEDICAL |
2345 WAUKEGAN ROAD |
SUITE 120 |
BANNOCKBURN,
IL
60015
|
|
Correspondent Contact |
LORI HAYS |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 12/21/2006 |
Decision Date | 02/09/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|