Eisai U.S.A., Inc. · Class I · Cleared Feb 11, 1987
| K-number | K864835 |
| Device name | TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR* |
| Applicant | Eisai U.S.A., Inc. |
| Product code | FCD |
| Device class | Class I |
| Decision date | Feb 11, 1987 |
| Decision | Substantially Equivalent |
| Regulation | 876.5210 |
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