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FDA 510(k), K050094, LADY COMP USA
FDA 510(k), K050094, LADY COMP USA
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510(K) Number: K050094
Device Name: LADY COMP USA
Manufacturer: MICHAEL CARTAIN
Device Classification Name: Device, Fertility Diagnostic, Proceptive
Regulation Number: LHD
Classification Product Code: KXA
Date Received: 01/14/2005
Decision Date: 04/20/2006
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: LADY COMP USA
Manufacturer: MICHAEL CARTAIN
Device Classification Name: Device, Fertility Diagnostic, Proceptive
Regulation Number: LHD
Classification Product Code: KXA
Date Received: 01/14/2005
Decision Date: 04/20/2006
Decision: 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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