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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brace, Drill
510(k) Number K892904
Device Name MITEK DRILL GUIDE
Applicant
Mitek Surgical Products, Inc.
990 Washington St.
Dedham,  MA  02026
Applicant Contact ROBERT P ZOLETTI
Correspondent
Mitek Surgical Products, Inc.
990 Washington St.
Dedham,  MA  02026
Correspondent Contact ROBERT P ZOLETTI
Regulation Number888.4540
Classification Product Code
HXY  
Date Received04/20/1989
Decision Date 09/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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