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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K950070
Device Name MITEK TOGGLE ANCHOR(TM)
Applicant
Mitek Surgical Products, Inc.
60 Glacier Dr.
Westwood,  MA  02090
Applicant Contact EDWARD F KENT
Correspondent
Mitek Surgical Products, Inc.
60 Glacier Dr.
Westwood,  MA  02090
Correspondent Contact EDWARD F KENT
Regulation Number888.3030
Classification Product Code
JDR  
Date Received01/09/1995
Decision Date 05/22/1995
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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