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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K812932
Device Name ANERIOD GAUZE
Applicant
Abco Dealers, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Abco Dealers, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.1435
Classification Product Code
DXG  
Date Received10/20/1981
Decision Date 12/02/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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