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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bath, Sitz, Nonpowered
510(k) Number K851309
Device Name ABCO PLASTIC UTENSILS
Applicant
Abco Dealers, Inc.
P.O. Box 17587
6637 N. Sidney Place
Milwaukee,  WI  53217
Applicant Contact CHRISTINE MEMETH
Correspondent
Abco Dealers, Inc.
P.O. Box 17587
6637 N. Sidney Place
Milwaukee,  WI  53217
Correspondent Contact CHRISTINE MEMETH
Regulation Number890.5125
Classification Product Code
KTC  
Date Received04/02/1985
Decision Date 07/01/1985
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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