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FDA 510(k), K191666, Unscented W long plastic and cardboard applicator tampons
FDA 510(k), K191666, Unscented W long plastic and cardboard applicator tampons
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$149.00 USD
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510(K) Number: K191666
Device Name: Unscented W long plastic and cardboard applicator tampons
Manufacturer: Henri Lesage
Device Classification Name: Tampon, Menstrual, Unscented
Regulation Number: HEB
Classification Product Code: 06/21/2019
Date Received: 12/20/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: Unscented W long plastic and cardboard applicator tampons
Manufacturer: Henri Lesage
Device Classification Name: Tampon, Menstrual, Unscented
Regulation Number: HEB
Classification Product Code: 06/21/2019
Date Received: 12/20/2019
Decision Date: Substantially Equivalent (SESE)
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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