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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 K850465
Device Name CERVICAL COLLARS & HEAD HALTERS
Applicant
Abco Dealers, Inc.
P.O. Box 17587
6637 N. Sidney Pl.
Milwaukee,  WI  53217
Applicant Contact CHRISTINE NEMETH
Correspondent
Abco Dealers, Inc.
P.O. Box 17587
6637 N. Sidney Pl.
Milwaukee,  WI  53217
Correspondent Contact CHRISTINE NEMETH
Regulation Number890.3490
Classification Product Code
IQK  
Date Received01/28/1985
Decision Date 04/25/1985
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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