The following data is part of a premarket notification filed by Acacia, Inc. with the FDA for Intopo.
| Device ID | K894206 |
| 510k Number | K894206 |
| Device Name: | INTOPO |
| Classification | Syringe, Piston |
| Applicant | ACACIA, INC. P.O. BOX 1240 Loma Linda, CA 92354 |
| Contact | Margaret Lumia |
| Correspondent | Margaret Lumia ACACIA, INC. P.O. BOX 1240 Loma Linda, CA 92354 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-19 |
| Decision Date | 1989-10-27 |