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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K012047
Device Name 3I CALCIUM SULFATE BONE CEMENT
Applicant
Implant Innovations, Inc.
56 E. Bell Dr.
Warsaw,  IN  46582
Applicant Contact MARY L VERSTYNEN
Correspondent
Implant Innovations, Inc.
56 E. Bell Dr.
Warsaw,  IN  46582
Correspondent Contact MARY L VERSTYNEN
Regulation Number872.3930
Classification Product Code
LYC  
Date Received06/29/2001
Decision Date 09/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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