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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 K935321
Device Name INNOVASIVE SUTURE BONE FASTENER WITH SUTURE
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 Number888.3030
Classification Product Code
JDR  
Date Received11/04/1993
Decision Date 10/19/1994
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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