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FDA 510(k), K140780, KEGEL SMART, KEGELSMART PEARL
FDA 510(k), K140780, KEGEL SMART, KEGELSMART PEARL
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510(K) Number: K140780
Device Name: KEGEL SMART, KEGELSMART PEARL
Manufacturer: REGULATORY INSIGHT, INC.
Device Classification Name: perineometer
Regulation Number: 884.1425
Classification Product Code: HIR
Date Received: 03/28/2014
Decision Date: 09/10/2014
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: KEGEL SMART, KEGELSMART PEARL
Manufacturer: REGULATORY INSIGHT, INC.
Device Classification Name: perineometer
Regulation Number: 884.1425
Classification Product Code: HIR
Date Received: 03/28/2014
Decision Date: 09/10/2014
Regulation Medical Specialty: Obstetrics/Gynecology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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