VOYAGER PERITONEAL DIALYSIS SYSTEM
FDA 510(k) clearance K103220 · decided 2011-07-29
Clearance details
- K-number
- K103220
- Device name
- VOYAGER PERITONEAL DIALYSIS SYSTEM
- Applicant
- Deka Research & Development Corp.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-01
- Decision date
- 2011-07-29
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- FKX
- Device class
- 2
- Regulation number
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Manchester, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.