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FDA 510(k), K081385, URESTA PESSARY
FDA 510(k), K081385, URESTA PESSARY
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510(K) Number: K081385
Device Name: URESTA PESSARY
Manufacturer: SHIRLEY FURESZ
Device Classification Name: Pessary, Vaginal
Regulation Number: HHW
Classification Product Code: KXA
Date Received: 05/16/2008
Decision Date: 10/09/2008
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: URESTA PESSARY
Manufacturer: SHIRLEY FURESZ
Device Classification Name: Pessary, Vaginal
Regulation Number: HHW
Classification Product Code: KXA
Date Received: 05/16/2008
Decision Date: 10/09/2008
Decision: Substantially Equivalent (SESE)
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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