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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K851312
Device Name ABCO ISOLATION MASKS
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
Date Received04/02/1985
Decision Date 05/01/1985
Decision Substantially Equivalent (SESE)
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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