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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 K881418
Device Name CRANIOTOME BLADE OR NEURO BLADE
Applicant
Nuell Air Equipment & Hospital Supplies, Inc.
P.O. Box 55
Warsaw,  IN  46581
Applicant Contact DARLENE HOLSCLAW
Correspondent
Nuell Air Equipment & Hospital Supplies, Inc.
P.O. Box 55
Warsaw,  IN  46581
Correspondent Contact DARLENE HOLSCLAW
Regulation Number882.4310
Classification Product Code
HBE  
Date Received04/04/1988
Decision Date 05/31/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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