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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Driver, Wire, And Bone Drill, Manual
510(k) Number K871834
Device Name DRILL, HAND, BONE, SMEDBERG
Applicant
Military Engineering, Inc.
P.O. Box J 2135 Western
Ave.
Plymouth,  IN  46563
Applicant Contact ROBERT W FRANCIS
Correspondent
Military Engineering, Inc.
P.O. Box J 2135 Western
Ave.
Plymouth,  IN  46563
Correspondent Contact ROBERT W FRANCIS
Regulation Number872.4120
Classification Product Code
DZJ  
Date Received05/12/1987
Decision Date 07/31/1987
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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