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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K981789
Device Name LORENZ PECTUS SUPPORT BAR STABILIZER
Applicant
Walter Lorenz Surgical, Inc.
1520 Tradeport Dr.
Jacksonville,  FL  32218
Applicant Contact DIANE PRESTON
Correspondent
Walter Lorenz Surgical, Inc.
1520 Tradeport Dr.
Jacksonville,  FL  32218
Correspondent Contact DIANE PRESTON
Regulation Number888.3030
Classification Product Code
HRS  
Date Received05/20/1998
Decision Date 07/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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