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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resins, Ion-Exchange
510(k) Number K890997
Device Name ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC)
Applicant
Atlantic Wholesale, Inc.
Post Office Box 76
Alpharetta,  GA  30239
Applicant Contact ERIC E GILMER
Correspondent
Atlantic Wholesale, Inc.
Post Office Box 76
Alpharetta,  GA  30239
Correspondent Contact ERIC E GILMER
Regulation Number862.2230
Classification Product Code
KEA  
Date Received02/27/1989
Decision Date 03/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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