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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 K953385
Device Name LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM
Applicant
WALTER LORENZ SURGICAL, INC.
1520 TRADEPORT DR.
JACKSONVILLE,  FL  32218 -2480
Applicant Contact W. DUTCH HARRISON
Correspondent
WALTER LORENZ SURGICAL, INC.
1520 TRADEPORT DR.
JACKSONVILLE,  FL  32218 -2480
Correspondent Contact W. DUTCH HARRISON
Regulation Number872.4760
Classification Product Code
JEY  
Date Received07/19/1995
Decision Date 09/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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