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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 K931253
Device Name QUICKANCHOR II
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 Number888.3030
Classification Product Code
JDR  
Date Received03/12/1993
Decision Date 06/16/1994
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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