QCR SYSTEM I AND QCR SYSTEM II
Device Facts
| Record ID | K893380 |
|---|---|
| Device Name | QCR SYSTEM I AND QCR SYSTEM II |
| Applicant | Bremer Mfg. & Tool Co., Inc. |
| Product Code | LGH · Orthopedic |
| Decision Date | Nov 16, 1989 |
| 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.
