KARL STORZ Endoscopy-America, Inc. · Class II · Cleared Oct 10, 2008
| K-number | K082046 |
| Device name | KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO |
| Applicant | KARL STORZ Endoscopy-America, Inc. |
| Product code | FBO |
| Device class | Class II |
| Decision date | Oct 10, 2008 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
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