CONDOM— 510(k) K960710
Substantially EquivalentPolar Latex , Ltd.
FDA 510(k) clearance K960710 for CONDOM, Substantially Equivalent on 1996-10-10. Applicant: Polar Latex , Ltd.. Device class: 2.
Clearance details
- Applicant
- Polar Latex , Ltd.
- Product code
- Code HIS
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Julian, CA, US
Recent devices under product code HIS
view allData sourced from openFDA. This site is unofficial and independent of the FDA.