PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS— 510(k) K950602
Substantially EquivalentReprocessing Products Corp
FDA 510(k) clearance K950602 for PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS, Substantially Equivalent on 1995-11-30. Applicant: Reprocessing Products Corp. Device class: 2.
Clearance details
- Applicant
- Reprocessing Products Corp
- Product code
- Code FJI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tucson, AZ, US
Recent devices under product code FJI
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- K090338 — ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE
- K974426 — POTENCY TEST STRIPS, INDICATOR TEST STRIPS
- K974064 — MICRO X RESIDUAL TEST STRIPS
Adverse events under product code FJI
product code FJI- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.