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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 K781974
Device Name IMPLANT DRIVERS AND TIPS
Applicant
Miter, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Miter, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.4120
Classification Product Code
DZJ  
Date Received11/27/1978
Decision Date 12/28/1978
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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