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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K953877
Device Name MITEK GII ANCHOR
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 Number888.3040
Classification Product Code
MBI  
Date Received07/17/1995
Decision Date 12/29/1995
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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