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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 K897155
Device Name MITEK ANCHOR(TM)
Applicant
Mitek Surgical Products, Inc.
57 Providence Hwy.
Norwood,  MA  02062
Applicant Contact P ZOLETTI
Correspondent
Mitek Surgical Products, Inc.
57 Providence Hwy.
Norwood,  MA  02062
Correspondent Contact P ZOLETTI
Regulation Number888.3030
Classification Product Code
JDR  
Date Received12/26/1989
Decision Date 04/04/1990
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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