The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Itm Sonic Surgery System.
| Device ID | K912931 |
| 510k Number | K912931 |
| Device Name: | ITM SONIC SURGERY SYSTEM |
| Classification | Instrument, Surgical, Sonic And Accessory/attachment |
| Applicant | BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Product Code | JDX |
| CFR Regulation Number | 888.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-05 |
| Decision Date | 1991-10-03 |