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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, Biodegradable, Soft Tissue
510(k) Number K994269
Device Name TITAN RC TACK
Applicant
Innovasive Devices, Inc.
734 Forest St.
Marlboro,  MA  01752
Applicant Contact KATHLEEN MORAHAN
Correspondent
Innovasive Devices, Inc.
734 Forest St.
Marlboro,  MA  01752
Correspondent Contact KATHLEEN MORAHAN
Regulation Number888.3030
Classification Product Code
MAI  
Date Received12/20/1999
Decision Date 01/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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