SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003— 510(k) K000420
Substantially EquivalentRetinalabs.Com
FDA 510(k) clearance K000420 for SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003, Substantially Equivalent on 2000-05-08. Applicant: Retinalabs.Com. Device class: 2.
Clearance details
- Applicant
- Retinalabs.Com
- Product code
- Code MRH
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Atlanta, GA, US
Recent devices under product code MRH
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view all- K003036 — TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025
- K000418 — PDT DOSECALCULATOR, MODEL 80000
- K000457 — VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES
- K000416 — TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001
Data sourced from openFDA. This site is unofficial and independent of the FDA.