The following data is part of a premarket notification filed by Dabi-atlante America Corp. with the FDA for Miniflex And Personal Unit.
| Device ID | K912997 |
| 510k Number | K912997 |
| Device Name: | MINIFLEX AND PERSONAL UNIT |
| Classification | Light, Operating, Dental |
| Applicant | DABI-ATLANTE AMERICA CORP. 5453 WEST WATERS AVE. STE. 200 Tampa, FL 33634 |
| Contact | R Fernandes |
| Correspondent | R Fernandes DABI-ATLANTE AMERICA CORP. 5453 WEST WATERS AVE. STE. 200 Tampa, FL 33634 |
| Product Code | EAZ |
| CFR Regulation Number | 872.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-08 |
| Decision Date | 1991-10-30 |