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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Non-Alterable
510(k) Number K031034
Device Name SPIN DOWN RAPIDFLAP
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 Number882.5330
Classification Product Code
GXN  
Date Received04/01/2003
Decision Date 05/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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