Swan Valley Medical, Incorporated · Class II · Cleared Oct 26, 2012
| K-number | K120127 |
| Device name | SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM |
| Applicant | Swan Valley Medical, Incorporated |
| Product code | KOB |
| Device class | Class II |
| Decision date | Oct 26, 2012 |
| Decision | Substantially Equivalent |
| Regulation | 876.5090 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov