Biomedical Ent., Inc. · Class II · Cleared Mar 13, 2001
| K-number | K001353 |
| Device name | MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM |
| Applicant | Biomedical Ent., Inc. |
| Product code | HBW |
| Device class | Class II |
| Decision date | Mar 13, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 882.5360 |
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