O-RING Condom
FDA 510(k) clearance K150828 · decided 2015-12-18
Clearance details
- K-number
- K150828
- Device name
- O-RING Condom
- Applicant
- O-Ring Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-03-30
- Decision date
- 2015-12-18
- Days to decision
- 263 days
- Clearance type
- Abbreviated
- Product code
- HIS
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Raleigh, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.