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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 K062842
FOIA Releasable 510(k) K062842
Device Name TWIST DRILL
Applicant
WALTER LORENZ SURGICAL, INC.
1520 TRADEPORT DR.
JACKSONVILLE,  FL  32218
Applicant Contact KIM REED
Correspondent
WALTER LORENZ SURGICAL, INC.
1520 TRADEPORT DR.
JACKSONVILLE,  FL  32218
Correspondent Contact KIM REED
Regulation Number882.4310
Classification Product Code
HBE  
Date Received09/22/2006
Decision Date 12/04/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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