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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
510(k) Number K800108
Device Name BASHAW CERVICAL IMMOBILIZER DEVICE
Applicant
Bashaw Custom Specialties, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Bashaw Custom Specialties, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3490
Classification Product Code
IQK  
Date Received01/16/1980
Decision Date 02/29/1980
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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