The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Force Fiber Green Ultra High Molecular Weight Polyethylene Non Absorbable Sutures Model:x-5000ffk, X-5001ffk, X-5002ffk.
| Device ID | K100506 |
| 510k Number | K100506 |
| Device Name: | FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | TELEFLEX MEDICAL 5307 95TH AVENUE Kenosha, WI 53144 |
| Contact | Valerie Followell |
| Correspondent | Valerie Followell TELEFLEX MEDICAL 5307 95TH AVENUE Kenosha, WI 53144 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-22 |
| Decision Date | 2010-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818614020096 | K100506 | 000 |
| B048VAL0236GL0 | K100506 | 000 |