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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, Alterable
510(k) Number K861822
Device Name MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI
Applicant
Valley Forge Scientific Corp.
P.O. Box 925
Valley Forge,  PA  19482
Applicant Contact JERRY MALIS
Correspondent
Valley Forge Scientific Corp.
P.O. Box 925
Valley Forge,  PA  19482
Correspondent Contact JERRY MALIS
Regulation Number882.5320
Classification Product Code
GWO  
Date Received05/12/1986
Decision Date 07/11/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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