SAFYRE SLING SYSTEM— 510(k) K020007
Substantially EquivalentPromedon
FDA 510(k) clearance K020007 for SAFYRE SLING SYSTEM, Substantially Equivalent on 2002-03-21. Applicant: Promedon. Device class: 2.
Clearance details
- Applicant
- Promedon
- Product code
- Code OTN
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Essex Junction, VT, US
Recent devices under product code OTN
view all- K231549 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
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- K211975 — Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
- K211223 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
More clearances from Promedon
view allAdverse events under product code OTN
product code OTN- Injury
- 6,630
- Total
- 6,630
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.