The following data is part of a premarket notification filed by Arrow Industries Llc with the FDA for Uniport Self-contained Portable Dental Unit.
| Device ID | K040117 |
| 510k Number | K040117 |
| Device Name: | UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT |
| Classification | Unit, Operative Dental |
| Applicant | ARROW INDUSTRIES LLC 530 5TH STREET Neche, ND 58265 -4033 |
| Contact | Robert Symington |
| Correspondent | Robert Symington ARROW INDUSTRIES LLC 530 5TH STREET Neche, ND 58265 -4033 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-20 |
| Decision Date | 2004-04-21 |
| Summary: | summary |