The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Femoral Canal Brush, Acetabular Brush.
| Device ID | K941605 |
| 510k Number | K941605 |
| Device Name: | STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH |
| Classification | Orthopedic Manual Surgical Instrument |
| Applicant | STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Cathy L Cadwallader |
| Correspondent | Cathy L Cadwallader STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | LXH |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-01 |
| Decision Date | 1994-08-05 |