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FDA 510(k), K083208, SATURN ACTIVE LASER SYSTEM
FDA 510(k), K083208, SATURN ACTIVE LASER SYSTEM
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510(K) Number: K083208
Device Name: SATURN ACTIVE LASER SYSTEM
Manufacturer:
Device Classification Name: System, Assisted Reproduction Laser
Regulation Number: MRX
Classification Product Code: 10/31/2008
Date Received: 08/25/2009
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: SATURN ACTIVE LASER SYSTEM
Manufacturer:
Device Classification Name: System, Assisted Reproduction Laser
Regulation Number: MRX
Classification Product Code: 10/31/2008
Date Received: 08/25/2009
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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