O-RING Condom— 510(k) K150828
Substantially EquivalentO-Ring Products, LLC
FDA 510(k) clearance K150828 for O-RING Condom, Substantially Equivalent on 2015-12-18. Applicant: O-Ring Products, LLC. Device class: 2.
Clearance details
- Applicant
- O-Ring Products, LLC
- 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
- Abbreviated
- Location
- Raleigh, NC, US
Recent devices under product code HIS
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