The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Atd Automatic Bridge Remover.
| Device ID | K992649 |
| 510k Number | K992649 |
| Device Name: | ATD AUTOMATIC BRIDGE REMOVER |
| Classification | Remover, Crown |
| Applicant | J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington, DC 20005 |
| Contact | Keith A Barritt |
| Correspondent | Keith A Barritt J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington, DC 20005 |
| Product Code | EIS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-06 |
| Decision Date | 1999-10-29 |