The following data is part of a premarket notification filed by Eisai U.s.a., Inc. with the FDA for Takane Auto Enemator Models 1200r/g1300tr/g1300sr*.
| Device ID | K864835 |
| 510k Number | K864835 |
| Device Name: | TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR* |
| Classification | Barium Enema Kit |
| Applicant | EISAI U.S.A., INC. 20908 HIGGINS COURT Torrance, CA 90501 |
| Contact | Minoru Abe |
| Correspondent | Minoru Abe EISAI U.S.A., INC. 20908 HIGGINS COURT Torrance, CA 90501 |
| Product Code | FCD |
| CFR Regulation Number | 876.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-09 |
| Decision Date | 1987-02-11 |