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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K043190
Device Name SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
Applicant
Innova Life Sciences Corp.
555 13th St., NW
Washington,  DC  20004
Applicant Contact HOWARD HOLSTEIN
Correspondent
Innova Life Sciences Corp.
555 13th St., NW
Washington,  DC  20004
Correspondent Contact HOWARD HOLSTEIN
Regulation Number872.3630
Classification Product Code
NHA  
Date Received11/17/2004
Decision Date 12/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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