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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K021511
Device Name CYTOFLEX MESH
Applicant
Unicare Biomedical, Inc.
25951 La Cuesta Ave.
Laguna Hills,  CA  92653
Applicant Contact STAN YANG
Correspondent
Unicare Biomedical, Inc.
25951 La Cuesta Ave.
Laguna Hills,  CA  92653
Correspondent Contact STAN YANG
Regulation Number872.4760
Classification Product Code
JEY  
Date Received05/09/2002
Decision Date 08/06/2002
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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