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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 K090083
Device Name CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090
Applicant
UNICARE BIOMEDICAL, INC.
22971-B TRITON WAY
LAGUNA HILLS,  CA  92653
Applicant Contact STAN YANG
Correspondent
UNICARE BIOMEDICAL, INC.
22971-B TRITON WAY
LAGUNA HILLS,  CA  92653
Correspondent Contact STAN YANG
Regulation Number872.3930
Classification Product Code
LYC  
Date Received01/12/2009
Decision Date 03/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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