OMNICATH IMPLANTED CATHETER AND DEPOT— 510(k) K911775
Substantially EquivalentOmnitron Intl., Inc.
FDA 510(k) clearance K911775 for OMNICATH IMPLANTED CATHETER AND DEPOT, Substantially Equivalent on 1991-05-08. Applicant: Omnitron Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Omnitron Intl., Inc.
- Product code
- Code KXK
- Device class
- Class 2
- Regulation
- 21 CFR 892.5730
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
Recent devices under product code KXK
view allMore clearances from Omnitron Intl., Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.