NEEDLE, DIALYSIS
FDA 510(k) clearance K902564 · decided 1991-03-01
Clearance details
- K-number
- K902564
- Device name
- NEEDLE, DIALYSIS
- Applicant
- Gainor Medical Europe, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1990-06-11
- Decision date
- 1991-03-01
- Days to decision
- 263 days
- Clearance type
- Traditional
- Product code
- FIE
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mcdonough, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.