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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, cranial
510(k) Number K011433
Device Name BALLERT CRANIAL MOLDING HELMET
Applicant
GEMA, INC.
2434 W. PETERSON AVE.
CHICAGO,  IL  60659
Applicant Contact GENE BERNARDONI
Correspondent
GEMA, INC.
2434 W. PETERSON AVE.
CHICAGO,  IL  60659
Correspondent Contact GENE BERNARDONI
Regulation Number882.5970
Classification Product Code
MVA  
Date Received05/10/2001
Decision Date 06/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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