HOSPAL TIPSTOP— 510(k) K982818
Substantially EquivalentGambro Healthcare
FDA 510(k) clearance K982818 for HOSPAL TIPSTOP, Substantially Equivalent on 1998-10-21. Applicant: Gambro Healthcare. Device class: 1.
Clearance details
- Applicant
- Gambro Healthcare
- Product code
- Code KMF
- Device class
- Class 1
- Regulation
- 21 CFR 880.5090
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, CO, US
Recent devices under product code KMF
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- K990039 — GAMBRO DQM 200
- K982413 — COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS
- K982414 — GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS
- K980386 — HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)
Data sourced from openFDA. This site is unofficial and independent of the FDA.