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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 K961861
Device Name VARIOUS DENTAL IMPLANTS WITH COVER SCREWS
Applicant
Implant Management of America
10936 SW 138th Pl.
Miami,  FL  33186
Applicant Contact WILLIAM SIMMONS
Correspondent
Implant Management of America
10936 SW 138th Pl.
Miami,  FL  33186
Correspondent Contact WILLIAM SIMMONS
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/14/1996
Decision Date 08/22/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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