FDA 510(k), K181974, MyoSure XL Tissue Removal Device for Fluent
FDA 510(k), K181974, MyoSure XL Tissue Removal Device for Fluent
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510(K) Number: K181974
Device Name: MyoSure XL Tissue Removal Device for Fluent
Manufacturer: Hologic, Inc
Device Classification Name: Hysteroscope (And Accessories)
Regulation Number: 884.1690
Classification Product Code: HIH
Date Received: 07/24/2018
Decision Date: 08/23/2018
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: MyoSure XL Tissue Removal Device for Fluent
Manufacturer: Hologic, Inc
Device Classification Name: Hysteroscope (And Accessories)
Regulation Number: 884.1690
Classification Product Code: HIH
Date Received: 07/24/2018
Decision Date: 08/23/2018
Regulation Medical Specialty: Obstetrics/Gynecology
- 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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