OPHIRA MINI SLING SYSTEM
FDA 510(k) clearance K110420 · decided 2012-05-08
Clearance details
- K-number
- K110420
- Device name
- OPHIRA MINI SLING SYSTEM
- Applicant
- Promedon S.A
- Decision
- Substantially Equivalent
- Date received
- 2011-02-14
- Decision date
- 2012-05-08
- Days to decision
- 449 days
- Clearance type
- Traditional
- Product code
- PAH
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Piscataway, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.