Edwards Lifesciences, LLC · Class II · Cleared Apr 15, 2009
| K-number | K083623 |
| Device name | CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100 |
| Applicant | Edwards Lifesciences, LLC |
| Product code | KRH |
| Device class | Class II |
| Decision date | Apr 15, 2009 |
| Decision | Substantially Equivalent |
| Regulation | 870.3800 |
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