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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K982492
Device Name IMCOR DENTAL IMPLANT SYSTEM ACCESSORIES
Applicant
Imcor
8000 W. 78th St.
Suite 115
Minneapolis,  MN  55439
Applicant Contact ADRIAN COOPER
Correspondent
Imcor
8000 W. 78th St.
Suite 115
Minneapolis,  MN  55439
Correspondent Contact ADRIAN COOPER
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/17/1998
Decision Date 10/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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