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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 K914043
Device Name MIDWEST IMPLANT HEXED 3.75MM STANDARD THREAD IMPLA
Applicant
Midwest Implant Sales, Inc.
P.O. Box 681038
Schaumburg,  IL  60168
Applicant Contact JOHN T CORSTEN
Correspondent
Midwest Implant Sales, Inc.
P.O. Box 681038
Schaumburg,  IL  60168
Correspondent Contact JOHN T CORSTEN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/10/1991
Decision Date 12/09/1991
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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