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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 K890962
Device Name ORTHOPAEDIC STAPLES
Applicant
Ortho Spectrum, Inc.
P.O. Box 2020
8002 California Ave.
Fair Oaks,  CA  95628
Applicant Contact M. W MOONEY
Correspondent
Ortho Spectrum, Inc.
P.O. Box 2020
8002 California Ave.
Fair Oaks,  CA  95628
Correspondent Contact M. W MOONEY
Regulation Number888.3030
Classification Product Code
JDR  
Date Received02/27/1989
Decision Date 05/15/1989
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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