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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 K970423
Device Name INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE
Applicant
Innovasive Devices, Inc.
734 Forest St.
Marlboro,  MA  01752
Applicant Contact ERIC BANNON
Correspondent
Innovasive Devices, Inc.
734 Forest St.
Marlboro,  MA  01752
Correspondent Contact ERIC BANNON
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
FTL  
Date Received02/04/1997
Decision Date 04/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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