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FDA 510(k), K152723, Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
FDA 510(k), K152723, Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
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510(K) Number: K152723
Device Name: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
Manufacturer: HOLOGIC, INC
Device Classification Name: Hysteroscope (And Accessories)
Regulation Number: 884.1690
Classification Product Code: HIH
Date Received: 09/22/2015
Decision Date: 11/13/2015
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
Manufacturer: HOLOGIC, INC
Device Classification Name: Hysteroscope (And Accessories)
Regulation Number: 884.1690
Classification Product Code: HIH
Date Received: 09/22/2015
Decision Date: 11/13/2015
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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