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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 K982927
Device Name QUICK TAP SELF DRILLING SCREW
Applicant
Kinamed, Inc.
2192-C Anchor Ct.
Newbury Park,  CA  91320
Applicant Contact ROBERT BRUCE
Correspondent
Kinamed, Inc.
2192-C Anchor Ct.
Newbury Park,  CA  91320
Correspondent Contact ROBERT BRUCE
Regulation Number872.4880
Classification Product Code
DZL  
Date Received08/20/1998
Decision Date 09/08/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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