The following data is part of a premarket notification filed by Mattioli Engineering, Srl with the FDA for Dms-1000c Dermoabrader.
Device ID | K965256 |
510k Number | K965256 |
Device Name: | DMS-1000C DERMOABRADER |
Classification | Dermatome |
Applicant | MATTIOLI ENGINEERING, SRL VIALE MACHIAVELLI, 2/A Florence, IT 50125 |
Contact | Gian Franco Bernabei |
Correspondent | Gian Franco Bernabei MATTIOLI ENGINEERING, SRL VIALE MACHIAVELLI, 2/A Florence, IT 50125 |
Product Code | GFD |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-16 |
Decision Date | 1996-12-09 |