The following data is part of a premarket notification filed by Acuderm, Inc. with the FDA for Acu-syringe W/wo Needles.
| Device ID | K854877 |
| 510k Number | K854877 |
| Device Name: | ACU-SYRINGE W/WO NEEDLES |
| Classification | Syringe, Piston |
| Applicant | ACUDERM, INC. 3750 HACIENDA BLVD. Ft Lauderdale, FL 33314 |
| Contact | Charles Yeh |
| Correspondent | Charles Yeh ACUDERM, INC. 3750 HACIENDA BLVD. Ft Lauderdale, FL 33314 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-06 |
| Decision Date | 1986-02-19 |