Opus Medical, Inc. · Class II · Cleared Dec 30, 2003
| K-number | K033317 |
| Device name | SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070 |
| Applicant | Opus Medical, Inc. |
| Product code | OCW |
| Device class | Class II |
| Decision date | Dec 30, 2003 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
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