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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 K932041
Device Name XANCHOR SUTURE ATTACHMENT DEVICE
Applicant
Orthopaedic Biosystems
736 N. Country Club Dr.
Mesa,  AZ  85201
Applicant Contact KERRY ZANG
Correspondent
Orthopaedic Biosystems
736 N. Country Club Dr.
Mesa,  AZ  85201
Correspondent Contact KERRY ZANG
Regulation Number888.3030
Classification Product Code
JDR  
Date Received04/27/1993
Decision Date 08/12/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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