The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Csco Forehead Fixation System.
| Device ID | K963502 |
| 510k Number | K963502 |
| Device Name: | CSCO FOREHEAD FIXATION SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | HOWMEDICA CORP. 14540 BELTWOOD PARKWAY EAST Dallas, TX 75244 |
| Contact | Kristyn R Waski |
| Correspondent | Kristyn R Waski HOWMEDICA CORP. 14540 BELTWOOD PARKWAY EAST Dallas, TX 75244 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-03 |
| Decision Date | 1997-10-28 |
| Summary: | summary |