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FDA 510(k), K141434, SATURN 5 LASER
FDA 510(k), K141434, SATURN 5 LASER
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510(K) Number: K141434
Device Name: SATURN 5 LASER
Manufacturer: DAVID LANDSDOWNE
Device Classification Name: System, Assisted Reproduction Laser
Regulation Number: MRX
Classification Product Code: 05/30/2014
Date Received: 02/18/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: SATURN 5 LASER
Manufacturer: DAVID LANDSDOWNE
Device Classification Name: System, Assisted Reproduction Laser
Regulation Number: MRX
Classification Product Code: 05/30/2014
Date Received: 02/18/2015
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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