The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Force Fiber.
Device ID | K033654 |
510k Number | K033654 |
Device Name: | FORCE FIBER |
Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
Applicant | TELEFLEX MEDICAL 600 AIRPORT RD. Fall River, MA 02720 -4740 |
Contact | Lynn Matos |
Correspondent | Lynn Matos TELEFLEX MEDICAL 600 AIRPORT RD. Fall River, MA 02720 -4740 |
Product Code | GAT |
CFR Regulation Number | 878.5000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-11-21 |
Decision Date | 2004-01-15 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FORCE FIBER 76565784 2985950 Live/Registered |
Teleflex Incorporated 2003-12-05 |