BLOOD TUBING SETS (STERILE FLUID PATH)
FDA 510(k) clearance K080807 · decided 2008-07-18
Clearance details
- K-number
- K080807
- Device name
- BLOOD TUBING SETS (STERILE FLUID PATH)
- Applicant
- Nxstage Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-03-21
- Decision date
- 2008-07-18
- Days to decision
- 119 days
- Clearance type
- Special
- Product code
- FJK
- 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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