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FDA 510(k), K032644, KOLPEXIN SPHERE
FDA 510(k), K032644, KOLPEXIN SPHERE
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510(K) Number: K032644
Device Name: KOLPEXIN SPHERE
Manufacturer: ADAMED LTD.
Device Classification Name: pessary, vaginal
Regulation Number: 884.3575
Classification Product Code: HHW
Date Received: 08/27/2003
Decision Date: 05/28/2004
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: KOLPEXIN SPHERE
Manufacturer: ADAMED LTD.
Device Classification Name: pessary, vaginal
Regulation Number: 884.3575
Classification Product Code: HHW
Date Received: 08/27/2003
Decision Date: 05/28/2004
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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