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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 K131563
Device Name SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM
Applicant
OPUS KSD, INC.
62 Forest Street
Suite 300
Marlborough,  MA  01752
Applicant Contact ROSINA ROBINSON, RN, MED, RAC
Correspondent
APTIV SOLUTIONS
62 Forest Street
Suite 300
Marlborough,  MA  01752
Correspondent Contact ROSINA ROBINSON, RN, MED, RAC
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
QQS  
Date Received05/30/2013
Decision Date 04/09/2014
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
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