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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 K954338
Device Name INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER
Applicant
Innovasive Devices, Inc.
100 B S. St.
Hopkinton,  MA  01748
Applicant Contact ERIC BANNON
Correspondent
Innovasive Devices, Inc.
100 B S. St.
Hopkinton,  MA  01748
Correspondent Contact ERIC BANNON
Regulation Number888.3040
Classification Product Code
MBI  
Date Received09/18/1995
Decision Date 03/21/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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