NXSTAGE PUREFLOW SL
FDA 510(k) clearance K111174 · decided 2011-09-19
Clearance details
- K-number
- K111174
- Device name
- NXSTAGE PUREFLOW SL
- Applicant
- Nxstage Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-04-27
- Decision date
- 2011-09-19
- Days to decision
- 145 days
- Clearance type
- Special
- Product code
- FKR
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lawrence, MA, US
- Third-party review
- No
- Expedited review
- No
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