INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM— 510(k) K020786
Substantially EquivalentRosch AG Medizintechnic
FDA 510(k) clearance K020786 for INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM, Substantially Equivalent on 2002-09-25. Applicant: Rosch AG Medizintechnic. Device class: 2.
Clearance details
- Applicant
- Rosch AG Medizintechnic
- Product code
- Code KZE
- Device class
- Class 2
- Regulation
- 21 CFR 880.5430
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Berlin, DE
Recent devices under product code KZE
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- K110456 — PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
- K090959 — LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA
- K090003 — ZETAJET
Data sourced from openFDA. This site is unofficial and independent of the FDA.