pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Waltham
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- 920 Winter St.
- Statement or summary
- Summary
- Product code
- KPO
- Zip code
- 02451
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
- Decision date
- 2024-05-10
- Decision code
- SESE
- Country code
- US
- Device name
- pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
- Advisory committee
- GU
- Contact
- Timothy Groves
- K number
- K233950
- State
- MA
- Date received
- 2023-12-14
- Review advisory committee
- GU
- Postal code
- 02451
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.5820
- Device class
- 2
- Registration number
- 1225714, 3007137482, 1651896, 3010242164, 2183415, 1954315, 3016096143, 2431908, 1652176, 3038195011, 1835498, 3005162618, 3005578748, 1056186, 3012364195, 9611823, 1528807, 3013546115, 3013764800, 3027241826, 9610725, 3003591774, 9610270, 3032828299, 3004176176, 3003768032, 8030639, 3035708507, 3019131, 3003464075, 9616277, 2029275, 3027592507, 3043014136
- FEI number
- 3007137482, 405, 3002970979, 1000142899, 3010242164, 2183415, 3016096143, 2431908, 3038195011, 3012394756, 3005578748, 3003310249, 1000306431, 6898, 3012364195, 3001236991, 3013546115, 3013764800, 3027241826, 1527681, 3006475063, 3003591774, 3032828299, 3013942511, 3003463852, 3004176176, 3035708507, 3003464075, 3027592507, 3001451489, 3003244997, 3002807005, 1000132332, 3043014136