DISPOSABLE STORAGE CAP— 510(k) K010366
Substantially EquivalentMolded Products, Inc.
FDA 510(k) clearance K010366 for DISPOSABLE STORAGE CAP, Substantially Equivalent on 2001-11-28. Applicant: Molded Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Molded Products, Inc.
- 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
- Abbreviated
- Location
- Harlan, IA, US
Recent devices under product code FJI
view all- K190459 — Hemoflow F3 and F4 Dialyzers
- K122952 — NIPRO PUREFLUX-L HEMODIALYZER
- K043342 — POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
- K011148 — ULTRACONCENTRATOR SYSTEM
- K002761 — FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS
More clearances from Molded Products, Inc.
view allAdverse 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.