The following data is part of a premarket notification filed by Takara Belmont Usa, Inc. with the FDA for Ana-bel, Model 087d And Ana-bel Cm, Model 187-cm.
| Device ID | K040748 |
| 510k Number | K040748 |
| Device Name: | ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | TAKARA BELMONT USA, INC. 1129 BLOOMFIELD AVENUE West Caldwell, NJ 07006 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff TAKARA BELMONT USA, INC. 1129 BLOOMFIELD AVENUE West Caldwell, NJ 07006 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-23 |
| Decision Date | 2004-06-02 |
| Summary: | summary |