The following data is part of a premarket notification filed by Depuy Intl., Ltd. with the FDA for Deca Dermatome (micromotor System).
| Device ID | K945594 |
| 510k Number | K945594 |
| Device Name: | DECA DERMATOME (MICROMOTOR SYSTEM) |
| Classification | Dermatome |
| Applicant | DEPUY INTL., LTD. ST ANTHONY'S ROAD LEEDS, LS 11 8DT West Yorkshire, GB Ls11 8dt |
| Contact | Ian Waterhouse |
| Correspondent | Ian Waterhouse DEPUY INTL., LTD. ST ANTHONY'S ROAD LEEDS, LS 11 8DT West Yorkshire, GB Ls11 8dt |
| Product Code | GFD |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1995-06-05 |