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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
Recalls CDRH Recalls
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