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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Cervical-Thoracic, Rigid
510(k) Number K780489
Device Name SPINE BOARD
Applicant
Marullo, Baldwin, Frieden, Gatewood,
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Marullo, Baldwin, Frieden, Gatewood,
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3490
Classification Product Code
IQF  
Date Received03/27/1978
Decision Date 04/12/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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