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FDA 510(k), K071798, MONDEAL DISTAL RADIUS SYSTEM
FDA 510(k), K071798, MONDEAL DISTAL RADIUS SYSTEM
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510(K) Number: K071798
Device Name: MONDEAL DISTAL RADIUS SYSTEM
Manufacturer: JAY EVANS
Device Classification Name: Plate, Fixation, Bone
Regulation Number: HRS
Classification Product Code: 07/02/2007
Date Received: 09/17/2007
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: MONDEAL DISTAL RADIUS SYSTEM
Manufacturer: JAY EVANS
Device Classification Name: Plate, Fixation, Bone
Regulation Number: HRS
Classification Product Code: 07/02/2007
Date Received: 09/17/2007
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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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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