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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 K092788
Device Name PERIOPHIL BIPHASIC
Applicant
Cytophil, Inc.
2485 Corporate Circle
Unit 2
East Troy,  WI  53120
Applicant Contact VICTOR M BOWERS
Correspondent
Cytophil, Inc.
2485 Corporate Circle
Unit 2
East Troy,  WI  53120
Correspondent Contact VICTOR M BOWERS
Regulation Number872.3930
Classification Product Code
LYC  
Date Received09/10/2009
Decision Date 12/18/2009
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
Recalls CDRH Recalls
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