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FDA 510(k), K173351, Panpac Flexi Shelf Pessary
FDA 510(k), K173351, Panpac Flexi Shelf Pessary
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510(K) Number: K173351
Device Name: Panpac Flexi Shelf Pessary
Manufacturer: Yen-Ming Pan
Device Classification Name: Pessary, Vaginal
Regulation Number: HHW
Classification Product Code: KXA
Date Received: 10/25/2017
Decision Date: 10/31/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: Panpac Flexi Shelf Pessary
Manufacturer: Yen-Ming Pan
Device Classification Name: Pessary, Vaginal
Regulation Number: HHW
Classification Product Code: KXA
Date Received: 10/25/2017
Decision Date: 10/31/2018
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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