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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable
510(k) Number K131637
Device Name ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)
Applicant
ROTATION MEDICAL, INC.
15350 25TH AVENUE N
SUITE 100
PLYMOUTH,  MN  55447
Applicant Contact GAIL SCHROEDER
Correspondent
ROTATION MEDICAL, INC.
15350 25TH AVENUE N
SUITE 100
PLYMOUTH,  MN  55447
Correspondent Contact GAIL SCHROEDER
Regulation Number878.4750
Classification Product Code
GDW  
Date Received06/04/2013
Decision Date 07/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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