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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, laser scan
510(k) Number K081787
Device Name CAMLAB CRANIAL ORTHOSIS HELMET
Applicant
BIOSCULPTOR CORPORATION
2480 WEST 82ND STREET #8
hialeah,  FL  33016
Applicant Contact mark mazloff
Correspondent
BIOSCULPTOR CORPORATION
2480 WEST 82ND STREET #8
hialeah,  FL  33016
Correspondent Contact mark mazloff
Regulation Number882.5970
Classification Product Code
OAN  
Subsequent Product Code
MVA  
Date Received06/24/2008
Decision Date 01/27/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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