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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Intraosseous
510(k) Number K151540
Device Name MC BIO Supertack Tack 3mm, 4mm and 5mm
Applicant
Eli-Ka Technologies
209 Madison Ave. Suite-D
Monrovia,  CA  91016
Applicant Contact LUIGI GIROTTO
Correspondent
Eli-Ka Technologies
209 Madison Ave. Suite-D
Monrovia,  CA  91016
Correspondent Contact LUIGI GIROTTO
Regulation Number872.4880
Classification Product Code
DZL  
Date Received06/08/2015
Decision Date 05/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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