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FDA 510(k), K060764, SATURN 3 LASER SYSTEM
FDA 510(k), K060764, SATURN 3 LASER SYSTEM
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510(K) Number: K060764
Device Name: SATURN 3 LASER SYSTEM
Manufacturer: GRACE HOLLAND
Device Classification Name: System, Assisted Reproduction Laser
Regulation Number: MRX
Classification Product Code: KXA
Date Received: 03/21/2006
Decision Date: 03/12/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: SATURN 3 LASER SYSTEM
Manufacturer: GRACE HOLLAND
Device Classification Name: System, Assisted Reproduction Laser
Regulation Number: MRX
Classification Product Code: KXA
Date Received: 03/21/2006
Decision Date: 03/12/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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