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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K001219
Device Name MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE 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 Number872.4760
Classification Product Code
JEY  
Date Received04/17/2000
Decision Date 06/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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