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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 K153746
Device Name Dunamis Force DFX Tensile Tape
Applicant
Dunamis, LLC
693 Sherling Lake Rd. Apt.122
Greenville,  AL  36037
Applicant Contact Prithvi Raj Chavan
Correspondent
Compliance Systems International, LLC
1083 Delaware Ave.
Buffalo,  NY  14209
Correspondent Contact Robert O Dean
Regulation Number878.5000
Classification Product Code
GAT  
Date Received12/29/2015
Decision Date 03/03/2016
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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