The following data is part of a premarket notification filed by Gramsmed Llc with the FDA for Grams Absorbable Surgical Gut Suture Plain & Chromic.
| Device ID | K021043 |
| 510k Number | K021043 |
| Device Name: | GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC |
| Classification | Suture, Absorbable, Natural |
| 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 | GAL |
| CFR Regulation Number | 878.4830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-01 |
| Decision Date | 2002-06-21 |
| Summary: | summary |