CONTACT DETACH
FDA 510(k) clearance K041545 · decided 2004-06-30
Clearance details
- K-number
- K041545
- Device name
- CONTACT DETACH
- Applicant
- Unomedical A/S
- Decision
- Substantially Equivalent
- Date received
- 2004-06-09
- Decision date
- 2004-06-30
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Roskilde, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infu recall (Z-0524-2015) | Medtronic MiniMed Inc. | 2014-12-12 |