AUTOJECT 2 FOR GLASSY SYRINGE— 510(k) K122837
Substantially EquivalentOwen Mumford, Ltd.
FDA 510(k) clearance K122837 for AUTOJECT 2 FOR GLASSY SYRINGE, Substantially Equivalent on 2012-10-15. Applicant: Owen Mumford, Ltd.. Device class: 2.
Clearance details
- Applicant
- Owen Mumford, Ltd.
- Product code
- Code KZH
- Device class
- Class 2
- Regulation
- 21 CFR 880.6920
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Woodstock, Oxfordshire, GB
Recent devices under product code KZH
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view all- K223854 — Unistik® ShieldLock, Unistik VacuFlip
- K231124 — Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)
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- K222303 — Unistik® Pro
- K221613 — Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets
Adverse events under product code KZH
product code KZH- Other
- 1
- Total
- 1
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.