GENXCATHETER— 510(k) K963031
Substantially EquivalentGenx Intl., Inc.
FDA 510(k) clearance K963031 for GENXCATHETER, Substantially Equivalent on 1996-10-21. Applicant: Genx Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Genx Intl., Inc.
- Product code
- Code MFD
- Device class
- Class 2
- Regulation
- 21 CFR 884.5250
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Madison, CT, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.