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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, bone
510(k) Number K972322
Device Name LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES
Applicant
WALTER LORENZ SURGICAL, INC.
1520 TRADEPORT DR.
JACKSONVILLE,  FL  32218
Applicant Contact DIANA PRESTON
Correspondent
WALTER LORENZ SURGICAL, INC.
1520 TRADEPORT DR.
JACKSONVILLE,  FL  32218
Correspondent Contact DIANA PRESTON
Regulation Number872.4760
Classification Product Code
JEY  
Date Received06/20/1997
Decision Date 08/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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