KEGEL8 PELVIC EXERCISER, MODEL OPH 400— 510(k) K081480
Substantially EquivalentNe Services , Ltd.
FDA 510(k) clearance K081480 for KEGEL8 PELVIC EXERCISER, MODEL OPH 400, Substantially Equivalent on 2008-09-12. Applicant: Ne Services , Ltd.. Device class: 2.
Clearance details
- Applicant
- Ne Services , Ltd.
- Product code
- Code KPI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5320
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oxford, OH, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.