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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 K894150
Device Name COUNTERBORE FOR SS SUBMERGED SCREW PLANT
Applicant
Artech Corp.
14554 Lee Rd.
Chantilly,  VA  22021
Applicant Contact HENRY HAHN
Correspondent
Artech Corp.
14554 Lee Rd.
Chantilly,  VA  22021
Correspondent Contact HENRY HAHN
Regulation Number872.4120
Classification Product Code
DZJ  
Date Received06/14/1989
Decision Date 09/27/1989
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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