Edwards Laboratories · Class II · Cleared Mar 17, 1980
| K-number | K792441 |
| Device name | CARPENTIER-EDWARDS FLEX. ANNULOPLASTY |
| Applicant | Edwards Laboratories |
| Product code | KRH |
| Device class | Class II |
| Decision date | Mar 17, 1980 |
| Decision | Substantially Equivalent - Subject to Tracking & PMS |
| Regulation | 870.3800 |
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