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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20020451331625 | K894206 | 000 |
| 20020451100887 | K894206 | 000 |
| 20020451100870 | K894206 | 000 |
| 20020451100863 | K894206 | 000 |
| 20020451100856 | K894206 | 000 |
| 20020451100849 | K894206 | 000 |
| 20020451100832 | K894206 | 000 |
| 20020451101723 | K894206 | 000 |
| 20020451101457 | K894206 | 000 |
| 20020451101440 | K894206 | 000 |
| 20020451101433 | K894206 | 000 |
| 10020451101429 | K894206 | 000 |
| 20020451101419 | K894206 | 000 |
| 20020451101709 | K894206 | 000 |
| 10020451101467 | K894206 | 000 |
| 20020451100894 | K894206 | 000 |
| 20020451101198 | K894206 | 000 |
| 20020451101204 | K894206 | 000 |
| 20020451331618 | K894206 | 000 |
| 20020451331601 | K894206 | 000 |
| 20020451331595 | K894206 | 000 |
| 20020451331588 | K894206 | 000 |
| 20020451331571 | K894206 | 000 |
| 20020451331366 | K894206 | 000 |
| 20020451331359 | K894206 | 000 |
| 20020451331342 | K894206 | 000 |
| 20020451331335 | K894206 | 000 |
| 20020451331328 | K894206 | 000 |
| 20020451331311 | K894206 | 000 |
| 20020451101242 | K894206 | 000 |
| 20020451101235 | K894206 | 000 |
| 20020451101228 | K894206 | 000 |
| 20020451101211 | K894206 | 000 |
| 10020451101719 | K894206 | 000 |