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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 K012830
Device Name LERMAN & SON CRANIAL ORTHOSIS HELMET
Applicant
Lerman & Son
8710 Wilshire Blvd.
Beverly Hills,  CA  90211
Applicant Contact MAX LERMAN
Correspondent
Lerman & Son
8710 Wilshire Blvd.
Beverly Hills,  CA  90211
Correspondent Contact MAX LERMAN
Regulation Number882.5970
Classification Product Code
MVA  
Date Received08/23/2001
Decision Date 11/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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