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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Formaldehyde (Formalin, Formol)
510(k) Number K882268
Device Name ZINC FORMALIN CONCENTRATE
Applicant
Anatech, Ltd.
1020 Harts Lake Rd.
Battle Creek,  MI  49015
Applicant Contact FELDMAN, M.S.
Correspondent
Anatech, Ltd.
1020 Harts Lake Rd.
Battle Creek,  MI  49015
Correspondent Contact FELDMAN, M.S.
Regulation Number864.4010
Classification Product Code
IGG  
Date Received05/31/1988
Decision Date 06/15/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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