The following data is part of a premarket notification filed by Innovative Surgical Devices Corp. with the FDA for Bone Lavage System.
| Device ID | K926337 |
| 510k Number | K926337 |
| Device Name: | BONE LAVAGE SYSTEM |
| Classification | Lavage, Jet |
| Applicant | INNOVATIVE SURGICAL DEVICES CORP. 413 S. MARTHA ST. Stillwater, MN 55082 |
| Contact | Karen M Roche |
| Correspondent | Karen M Roche INNOVATIVE SURGICAL DEVICES CORP. 413 S. MARTHA ST. Stillwater, MN 55082 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-17 |
| Decision Date | 1993-06-11 |