The following data is part of a premarket notification filed by Gramsmed Llc with the FDA for Grams Nylon Nonabsorbable Suture.
| Device ID | K003000 |
| 510k Number | K003000 |
| Device Name: | GRAMS NYLON NONABSORBABLE SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| 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 | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-26 |
| Decision Date | 2000-12-18 |