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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bit, Surgical
510(k) Number K935225
Device Name MITEK MODULAR DRILL BIT
Applicant
Mitek Surgical Products, Inc.
57 Providence Hwy.
Norwood,  MA  02062
Applicant Contact Robert Zoletti
Correspondent
Mitek Surgical Products, Inc.
57 Providence Hwy.
Norwood,  MA  02062
Correspondent Contact Robert Zoletti
Regulation Number878.4820
Classification Product Code
GFG  
Date Received11/01/1993
Decision Date 04/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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