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FDA 510(k), K131637, ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)
FDA 510(k), K131637, ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)
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510(K) Number: K131637
Device Name: ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)
Manufacturer: GAIL SCHROEDER
Device Classification Name: Staple, Implantable
Regulation Number: GDW
Classification Product Code: 06/04/2013
Date Received: 07/12/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)
Manufacturer: GAIL SCHROEDER
Device Classification Name: Staple, Implantable
Regulation Number: GDW
Classification Product Code: 06/04/2013
Date Received: 07/12/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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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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