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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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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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