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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drills, Burrs, Trephines & Accessories (Simple, Powered)
510(k) Number K875224
Device Name HUDSON CRANINAL BURRS
Applicant
TRI-MED, INC.
P.O. BOX 701
WARSAW,  IN  46580
Applicant Contact DARLENE HOLSCLAW
Correspondent
TRI-MED, INC.
P.O. BOX 701
WARSAW,  IN  46580
Correspondent Contact DARLENE HOLSCLAW
Regulation Number882.4310
Classification Product Code
HBE  
Date Received12/22/1987
Decision Date 01/28/1988
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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