| K-number | K963630 |
| Device name | C.O.L.D.A. |
| Applicant | C.O.L.D.A. S.N.C. |
| Product code | HQY |
| Device class | Class I |
| Decision date | Oct 18, 1996 |
| Decision | Substantially Equivalent |
| Regulation | 886.5850 |
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