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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 K861137
Device Name ORTHOMED ORTHOPAEDIC FIXATION STAPLES
Applicant
Biomedical Exports, Inc.
P.O. Box 453
The Lawyer House, 718 Main St.
Suisun,  CA  94585
Applicant Contact M. W MOONEY
Correspondent
Biomedical Exports, Inc.
P.O. Box 453
The Lawyer House, 718 Main St.
Suisun,  CA  94585
Correspondent Contact M. W MOONEY
Regulation Number888.3030
Classification Product Code
JDR  
Date Received03/26/1986
Decision Date 04/17/1986
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
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