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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 (Manual)
510(k) Number K022370
Device Name FRAMELOCK; FRAMELOCK ACCESSORIES
Applicant
Medtronic Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Applicant Contact B.L. MCDERMOTT
Correspondent
Medtronic Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Correspondent Contact B.L. MCDERMOTT
Regulation Number882.4300
Classification Product Code
HBG  
Date Received07/22/2002
Decision Date 10/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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