SWISSTEK 2000(TM) CAST REMOVAL SYSTEM
Device Facts
| Record ID | K932653 |
|---|---|
| Device Name | SWISSTEK 2000(TM) CAST REMOVAL SYSTEM |
| Applicant | Carapace, Inc. |
| Product Code | LGH · Orthopedic |
| Decision Date | Jan 28, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.5960 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A cast removal instrument is an AC-powered, hand-held device intended to remove a cast from a patient. This generic type of device includes the electric cast cutter and cast vacuum.
