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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene
510(k) Number K150327
Device Name Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2
Applicant
Dunamis, LLC
693 Sherling Lake Rd.
Greenville,  AL  36037
Applicant Contact Prithviraj Chavan
Correspondent
Lexamed
705 Front St.
Toledo,  OH  43605
Correspondent Contact Robert O Dean
Regulation Number878.5000
Classification Product Code
GAT  
Date Received02/10/2015
Decision Date 06/29/2015
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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