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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K932925
Device Name BONE ANCHOR FOR SOFT TISSUE ATTACHMENT
Applicant
Vesitec Medical, Inc.
26072 Merit Cir.
Suite 125
Laguna Hills,  CA  92653
Applicant Contact LINDA D'ABATE
Correspondent
Vesitec Medical, Inc.
26072 Merit Cir.
Suite 125
Laguna Hills,  CA  92653
Correspondent Contact LINDA D'ABATE
Regulation Number888.3030
Classification Product Code
JDR  
Date Received06/15/1993
Decision Date 04/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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