The following data is part of a premarket notification filed by Prothia Usa, Inc. with the FDA for Ampligreffe.
| Device ID | K830993 |
| 510k Number | K830993 |
| Device Name: | AMPLIGREFFE |
| Classification | Dermatome |
| Applicant | PROTHIA USA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GFD |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-29 |
| Decision Date | 1983-05-03 |