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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Halter, Head, Traction
510(k) Number K770910
Device Name MEDISHIELD CERVICAL COLLAR
Applicant
Fraser Sweatman, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Fraser Sweatman, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.5890
Classification Product Code
HSS  
Date Received05/19/1977
Decision Date 05/25/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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