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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fastener, plate, cranioplasty
510(k) Number K001353
Device Name MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY 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 Number882.5360
Classification Product Code
HBW  
Date Received04/28/2000
Decision Date 03/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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