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FDA 510(k), K131635, ROTATION MEDICAL BONE STAPLE (RMB STAPLE)
FDA 510(k), K131635, ROTATION MEDICAL BONE STAPLE (RMB STAPLE)
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510(K) Number: K131635
Device Name: ROTATION MEDICAL BONE STAPLE (RMB STAPLE)
Manufacturer: GAIL SCHROEDER
Device Classification Name: Fastener, Fixation, Nondegradable, Soft Tissue
Regulation Number: MBI
Classification Product Code: 06/04/2013
Date Received: 08/29/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: ROTATION MEDICAL BONE STAPLE (RMB STAPLE)
Manufacturer: GAIL SCHROEDER
Device Classification Name: Fastener, Fixation, Nondegradable, Soft Tissue
Regulation Number: MBI
Classification Product Code: 06/04/2013
Date Received: 08/29/2013
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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