The following data is part of a premarket notification filed by Gramsmed Llc with the FDA for Grams Polyester Nonabsorbable Suture.
| Device ID | K003590 |
| 510k Number | K003590 |
| Device Name: | GRAMS POLYESTER NONABSORBABLE SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | GRAMSMED LLC 2225 DAKOTA DR. Grafton, WI 53024 |
| Contact | Anthony J Dimercurio |
| Correspondent | Anthony J Dimercurio GRAMSMED LLC 2225 DAKOTA DR. Grafton, WI 53024 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-21 |
| Decision Date | 2001-03-05 |