STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA
Device Facts
| Record ID | K950308 |
|---|---|
| Device Name | STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA |
| Applicant | Solarcare Technologies Corp,Inc. |
| Product Code | JXS · Ear, Nose, Throat |
| Decision Date | Apr 14, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3540 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by a surgeon to construct ossicular replacements. This generic type of device includes the ear, nose, and throat cutting block; wire crimper, wire bending die; wire closure forceps; piston cutting jib; gelfoamTM punch; wire cutting scissors; and ossicular finger vise.
