The following data is part of a premarket notification filed by Acacia, Inc. with the FDA for Acacia Piston Syringe.
| Device ID | K092986 |
| 510k Number | K092986 |
| Device Name: | ACACIA PISTON SYRINGE |
| Classification | Syringe, Piston |
| Applicant | ACACIA, INC. 785 CHALLENGER STREET Brea, CA 92821 |
| Contact | Fergie Ferguson |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-09-28 |
| Decision Date | 2009-10-27 |
| Summary: | summary |