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FDA 510(k), K002617, PERIFORM PERINEOMETRIC PROBE, MODEL 8300
FDA 510(k), K002617, PERIFORM PERINEOMETRIC PROBE, MODEL 8300
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510(K) Number: K002617
Device Name: PERIFORM PERINEOMETRIC PROBE, MODEL 8300
Manufacturer: NEEN DESIGN LTD.
Device Classification Name: perineometer
Regulation Number: 884.1425
Classification Product Code: HIR
Date Received: 08/23/2000
Decision Date: 04/05/2001
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: PERIFORM PERINEOMETRIC PROBE, MODEL 8300
Manufacturer: NEEN DESIGN LTD.
Device Classification Name: perineometer
Regulation Number: 884.1425
Classification Product Code: HIR
Date Received: 08/23/2000
Decision Date: 04/05/2001
Regulation Medical Specialty: Obstetrics/Gynecology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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