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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Paddie
510(k) Number K844594
Device Name NEURO CUSTOM SURGICAL KIT
Applicant
XANMED CORP.
815 CONNECTICUT AVENUE NW
WASHINGTON,  DC  20006 -
Applicant Contact DAVID B VANCE
Correspondent
XANMED CORP.
815 CONNECTICUT AVENUE NW
WASHINGTON,  DC  20006 -
Correspondent Contact DAVID B VANCE
Regulation Number882.4700
Classification Product Code
HBA  
Date Received11/26/1984
Decision Date 06/13/1985
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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