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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 Ave. N.
Suite 100
Plymouth,  MN  55447
Applicant Contact GAIL SCHROEDER
Correspondent
Rotation Medical, Inc.
15350 25th Ave. 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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