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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 K993714
Device Name MEMOGRAPH STAPLE, WARM SYSTEM
Applicant
Biomedical Ent., Inc.
14785 Omicron Dr., Suite 205
San Antonio,  TX  78245
Applicant Contact W. CASEY FOX
Correspondent
Biomedical Ent., Inc.
14785 Omicron Dr., Suite 205
San Antonio,  TX  78245
Correspondent Contact W. CASEY FOX
Regulation Number888.3030
Classification Product Code
JDR  
Date Received11/02/1999
Decision Date 02/25/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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