The following data is part of a premarket notification filed by Precision Modified Devices with the FDA for Skin Mesh Device.
| Device ID | K861285 |
| 510k Number | K861285 |
| Device Name: | SKIN MESH DEVICE |
| Classification | Dermatome |
| Applicant | PRECISION MODIFIED DEVICES 1239 EAST 3800 SOUTH Salt Lake City, UT 84106 |
| Contact | Kathy M Smith |
| Correspondent | Kathy M Smith PRECISION MODIFIED DEVICES 1239 EAST 3800 SOUTH Salt Lake City, UT 84106 |
| Product Code | GFD |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-07 |
| Decision Date | 1986-04-17 |