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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Retractor
510(k) Number K882112
Device Name MURSE RETRACTOR
Applicant
Euro-American Marketing Group, Inc.
610 S. Albert
P.O. Box 823
Mount Prospect,  IL  60056
Applicant Contact BRENDA BORDEWYK
Correspondent
Euro-American Marketing Group, Inc.
610 S. Albert
P.O. Box 823
Mount Prospect,  IL  60056
Correspondent Contact BRENDA BORDEWYK
Regulation Number878.4800
Classification Product Code
GAD  
Date Received05/19/1988
Decision Date 06/15/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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