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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical
510(k) Number K112423
FOIA Releasable 510(k) K112423
Device Name COLLAGEN TENDON SHEET
Applicant
ROTATION MEDICAL, INC.
15350 25TH AVENUE N
SUITE 100
PLYMOUTH,  MN  55447
Applicant Contact JEFF SIMS
Correspondent
ROTATION MEDICAL, INC.
15350 25TH AVENUE N
SUITE 100
PLYMOUTH,  MN  55447
Correspondent Contact JEFF SIMS
Regulation Number878.3300
Classification Product Code
FTM  
Date Received08/23/2011
Decision Date 12/22/2011
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
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