FRESENIUS STERILE STAY SAFE CAP
FDA 510(k) clearance K083542 · decided 2008-12-29
Clearance details
- K-number
- K083542
- Device name
- FRESENIUS STERILE STAY SAFE CAP
- Applicant
- Fresenius Medical Care North America
- Decision
- Substantially Equivalent
- Date received
- 2008-11-28
- Decision date
- 2008-12-29
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- KDJ
- Device class
- 2
- Regulation number
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stay Safe Cap recall (Z-0507-2024) | Fresenius Medical Care Holdings, Inc. | 2023-12-07 |