The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Spaceline Emcia, Model Cu580.
| Device ID | K043496 |
| 510k Number | K043496 |
| Device Name: | SPACELINE EMCIA, MODEL CU580 |
| Classification | Unit, Operative Dental |
| Applicant | J. MORITA USA, INC. 1425 K ST. N.W. SUITE 1100 Washington, DC 20005 |
| Contact | Keith A Barritt |
| Correspondent | Keith A Barritt J. MORITA USA, INC. 1425 K ST. N.W. SUITE 1100 Washington, DC 20005 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-17 |
| Decision Date | 2005-02-16 |
| Summary: | summary |