The following data is part of a premarket notification filed by Sonokinetics, Inc. with the FDA for Acryl-x System Tm.
| Device ID | K911548 |
| 510k Number | K911548 |
| Device Name: | ACRYL-X SYSTEM TM |
| Classification | Instrument, Surgical, Sonic And Accessory/attachment |
| Applicant | SONOKINETICS, INC. 130 WASHINGTON ST. SUITE 201 Hoboken, NJ 07030 -4629 |
| Contact | David Wuchinich |
| Correspondent | David Wuchinich SONOKINETICS, INC. 130 WASHINGTON ST. SUITE 201 Hoboken, NJ 07030 -4629 |
| Product Code | JDX |
| CFR Regulation Number | 888.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-08 |
| Decision Date | 1991-06-28 |