The following data is part of a premarket notification filed by Beere Precision Medical Instruments, Kmedic, Telef with the FDA for Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures.
| Device ID | K092533 |
| 510k Number | K092533 |
| Device Name: | FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | BEERE PRECISION MEDICAL INSTRUMENTS, KMEDIC, TELEF 5307 95TH AVE. Kenosha, WI 53144 |
| Contact | Joy Voigt |
| Correspondent | Joy Voigt BEERE PRECISION MEDICAL INSTRUMENTS, KMEDIC, TELEF 5307 95TH AVE. 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 | 2009-08-19 |
| Decision Date | 2009-09-15 |
| Summary: | summary |