The following data is part of a premarket notification filed by Actio, Inc. with the FDA for Shape-actio Metal Toxicology Control.
| Device ID | K890721 |
| 510k Number | K890721 |
| Device Name: | SHAPE-ACTIO METAL TOXICOLOGY CONTROL |
| Classification | Heavy Metals Control Materials |
| Applicant | ACTIO, INC. 1127-57TH AVE. Oakland, CA 94621 |
| Contact | Lewin, Ph.d. |
| Correspondent | Lewin, Ph.d. ACTIO, INC. 1127-57TH AVE. Oakland, CA 94621 |
| Product Code | DIE |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-13 |
| Decision Date | 1989-04-10 |