The following data is part of a premarket notification filed by Mri Ventures, Inc. with the FDA for Dermaspandere.
| Device ID | K860925 |
| 510k Number | K860925 |
| Device Name: | DERMASPANDERE |
| Classification | Dermatome |
| Applicant | MRI VENTURES, INC. 425 VOLKER BLVD. Kansas City, MO 64110 |
| Contact | A. E Vandegrift |
| Correspondent | A. E Vandegrift MRI VENTURES, INC. 425 VOLKER BLVD. Kansas City, MO 64110 |
| Product Code | GFD |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-11 |
| Decision Date | 1986-03-28 |